FHIR Server FHIR Server Version n/a

Resource StructureDefinition/FHIR Server from package hl7.fhir.us.pq-cmc-fda#current (1875 ms)

Package
hl7.fhir.us.pq-cmc-fda
Type
StructureDefinition
FHIR Version
Source
http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/StructureDefinition-pqcmc-product-part.html
Url
http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part
Version
2.0.0-ballot
Status
active
Date
2025-02-08T00:27:10+00:00
Name
FinishedProduct
Title
Manufactured Drug Product
Experimental
False
Realm
Authority
hl7
Description
The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.
Type
ManufacturedItemDefinition
Kind
resource
Resources that use this resource

StructureDefinition
cmc-ectd-document-32p10
CMC eCTD 32P10 Document
ectd-composition-32p10
eCTD Product Description and Composition
Resources that this resource uses

StructureDefinition
codeable-concept-text-only
Text Only Codeable Concept
literal-codeable-reference
Literal Coded Reference
pq-amount-ratio
Amount Ratio
pqcmc-component
Drug Product Component
pqcmc-graphic-attachment
Analysis Graphic
pqcmc-pdf-attachment
Attached Document (PDF)
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category
Capsule Shell Classification Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose
Coating Purpose Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
Drug Product Component Function Category Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology
Excipient Function Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
Manufactured Dose Form Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
Non-Percentage Units
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
Percentage Units
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
Ingredient Location Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
Product Part Type Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
Quality Benchmark Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism
Release Mechanism Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile
Release Profile Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology
Strength Type Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
Units Of Measure
Narrative

Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition pqcmc-product-part
Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
identifier	S	0..1	Identifier	Unique identifier
status	S	1..1	code	draft \| active \| retired \| unknown
name	S	0..1	string	Product Proprietary Name \| Product Non-proprietary Name
manufacturedDoseForm		1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property	S	6..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type.text
property:All Slices				Content/Rules for all slices
type	S	1..1	CodeableConcept	A code expressing the type of characteristic
text	S	1..1	string	Plain text representation of the concept
property:OvrRelsProf	S	1..1	BackboneElement	Product Overall Release Profile
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech	S	0..1	BackboneElement	Product Overall Release Mechanism
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd	S	0..1	BackboneElement	Product Coating Indicator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Coating Indicator
value[x]	S	1..1	boolean	A value for the characteristic
property:LayCnt	S	0..1	BackboneElement	Product Tablet Layer Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:BeaTypCnt	S	0..1	BackboneElement	Tablet Bead Type Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:CapClass	S	0..1	BackboneElement	Capsule Shell Part Classification Category
type
text		0..1	string	Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	S	0..1	BackboneElement	Product Capsule Constituent Count
type
text		0..1	string	Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x]	S	1..1	Quantity	A value for the characteristic Required Pattern: At least the following
system		1..1	uri	System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code		1..1	code	Coded form of the unit Fixed Value: 1
value	S	1..1	decimal	Numerical value (with implicit precision)
property:Schematic	S	1..*	BackboneElement	Product Schematic
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Schematic
value[x]	S	1..1	GraphicAttachment, PDFAttachment	A value for the characteristic
property:WgtTyp	S	1..1	BackboneElement	Product Weight Type
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Weight Type
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum	S	1..1	BackboneElement	Product Total Weight Numeric Numerator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x]	S	1..1	Quantity	A value for the characteristic Binding: Units Of Measure (extensible)
comparator	S	0..1	code	Product Total Weight Operator
property:TotWgtDen	S	0..1	BackboneElement	Product Total Weight Numeric Denominator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x]	S	1..1	SimpleQuantity	A value for the characteristic Binding: Units Of Measure (extensible)
value	S	1..1	decimal	Numerical value (with implicit precision)
property:TotWgtTxt	S	0..1	BackboneElement	Product Total Weight Textual
type
text		0..1	string	Plain text representation of the concept Required Pattern: Total Weight Textual
value[x]	S	1..1	markdown	A value for the characteristic
property:QualStd	S	1..*	BackboneElement	Product Quality Standard
type
text		0..1	string	Plain text representation of the concept Required Pattern: Quality Standard
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile	S	1..1	BackboneElement	Sterile Product Indicator
type
text		0..1	string	Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x]	S	1..1	boolean	A value for the characteristic
component	SC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio	S	0..1	AmountRatio	Amount Ratio
type	S	1..1	CodeableConcept	Product Part Type
coding		0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function	S	0..*	CodeableConceptTextOnly	Product Part Function Description
Slices for amount	S	0..2	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight	S	0..1	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value	S	1..1	decimal	Product Part Total Weight Numeric
unit	S	1..1	string	Product Part Total Weight Numeric UOM
code		0..1	code	property:PPiDref	S	0..1	BackboneElement	Product Part Identifier Reference
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x]	S	1..1	CodeableConceptTextOnly	A value for the characteristic
property:RelsProf	S	1..1	BackboneElement	Product Part Release Profile
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech	S	0..1	BackboneElement	Product Part Release Mechanism
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose	S	0..*	BackboneElement	Coating Product Part Purpose
type
text		0..1	string	Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color	S	0..1	BackboneElement	Product Part Color Description
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Color Description
value[x]	S	1..1	CodeableConceptTextOnly	A value for the characteristic
property:AddInfo	S	0..1	BackboneElement	Product Part Additional Information
type
text		0..1	string	Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x]	S	1..1	markdown	A value for the characteristic
component	S	0..*		A component that this component contains or is made from
Documentation for this format
Source

{
  "resourceType" : "StructureDefinition",
  "id" : "pqcmc-product-part",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition pqcmc-product-part</b></p><a name=\"pqcmc-product-part\"> </a><a name=\"hcpqcmc-product-part\"> </a><a name=\"pqcmc-product-part-en-US\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition\">ManufacturedItemDefinition</a><a name=\"ManufacturedItemDefinition\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/manufactureditemdefinition.html\">ManufacturedItemDefinition</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product</span><br/><span style=\"font-weight:bold\">cmc-capsule-count-required: </span>Capsule constituent count is required when the dosage form is 'Capsule'<br/><span style=\"font-weight:bold\">cmc-arbitrary-unit-text-required: </span>BR â€“ Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual<br/><span style=\"font-weight:bold\">cmc-coating-indication-required: </span>Coating indication is required when the dosage form is a tablet, lozenge or capsule<br/><span style=\"font-weight:bold\">cmc-tablet-layer-count-required: </span>Tablet layer count is required when the dosage form is a tablet<br/><span style=\"font-weight:bold\">cmc-tablet-bead-count-required: </span>Tablet bead count is required when the dosage form is a tablet<br/><span style=\"font-weight:bold\">cmc-capsule-classification-required: </span>when the the dosage form is 'capsule' and a 'capsule shell' part\nexists, a capsule shell part classification is mandatory<br/><span style=\"font-weight:bold\">cmc-component-id-ref: </span>If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.identifier\">identifier</a><a name=\"ManufacturedItemDefinition.identifier\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Identifier\">Identifier</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Unique identifier</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.status\">status</a><a name=\"ManufacturedItemDefinition.status\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">draft | active | retired | unknown</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.name\" title=\"Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. \nExample: Tylenol\n\nProduct Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]\">name</a><a name=\"ManufacturedItemDefinition.name\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Proprietary Name | Product Non-proprietary Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.manufacturedDoseForm\">manufacturedDoseForm</a><a name=\"ManufacturedItemDefinition.manufacturedDoseForm\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Dose form as manufactured (before any necessary transformation)</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-manufactured-dose-form-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology\">Manufactured Dose Form Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property\">Slices for property</a><a name=\"ManufacturedItemDefinition.property\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"font-style: italic\">6</span><span style=\"font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5; font-style: italic\">General characteristics of this item</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Closed by value:type.text</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck133.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> property:All Slices<a name=\"ManufacturedItemDefinition.property.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Content/Rules for all slices</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1321.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property.type\">type</a><a name=\"ManufacturedItemDefinition.property.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A code expressing the type of characteristic</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13200.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsProf\" title=\"Slice OvrRelsProf: The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids).\nFor example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the &quot;product overall release profile&quot; is &quot;ER&quot;. [Source: SME Defined]\">property:OvrRelsProf</a><a name=\"ManufacturedItemDefinition.property.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Overall Release Profile</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsProf.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsProf.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Product Overall Release Profile</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsProf.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-release-profile.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile\">Release Profile Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsMech\" title=\"Slice OvrRelsMech: The dosage form design used to achieve an ER release profile.  Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]\">property:OvrRelsMech</a><a name=\"ManufacturedItemDefinition.property.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Overall Release Mechanism</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsMech.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsMech.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Product Overall Release Mechanism</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:OvrRelsMech.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-release-mechanism.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism\">Release Mechanism Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CoatInd\" title=\"Slice CoatInd: A property that identifies whether the drug product contains any coatings. [Source: SME Defined]\">property:CoatInd</a><a name=\"ManufacturedItemDefinition.property.5\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Coating Indicator</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CoatInd.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CoatInd.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Coating Indicator</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CoatInd.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:LayCnt\" title=\"Slice LayCnt: The total number of layers in the tablet. [Source: SME Defined]\nNote: Non-layered tablets will be considered as one layer tablets.\">property:LayCnt</a><a name=\"ManufacturedItemDefinition.property.6\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Tablet Layer Count</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:LayCnt.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.5\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:LayCnt.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.5\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Tablet Layer Count</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:LayCnt.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Quantity.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">System that defines coded unit form<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://unitsofmeasure.org</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Quantity.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Coded form of the unit<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">1</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:LayCnt.value[x].value\">value</a><a name=\"ManufacturedItemDefinition.property.value_x_.value\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Numerical value (with implicit precision)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:BeaTypCnt\" title=\"Slice BeaTypCnt: The total number of type of beads present in a tablet [Source: SME Defined]\nExample: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.\">property:BeaTypCnt</a><a name=\"ManufacturedItemDefinition.property.7\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Tablet Bead Type Count</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:BeaTypCnt.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.6\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:BeaTypCnt.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.6\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Tablet Bead Type Count</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:BeaTypCnt.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.5\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Quantity.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">System that defines coded unit form<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://unitsofmeasure.org</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Quantity.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Coded form of the unit<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">1</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:BeaTypCnt.value[x].value\">value</a><a name=\"ManufacturedItemDefinition.property.value_x_.value.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Numerical value (with implicit precision)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapClass\" title=\"Slice CapClass: Categorization of the capsule shell based on factors such as the shellâ€™s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]\">property:CapClass</a><a name=\"ManufacturedItemDefinition.property.8\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Capsule Shell Part Classification Category</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapClass.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.7\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapClass.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.7\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Capsule Classification Category</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapClass.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.6\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-capsule-classification-category.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category\">Capsule Shell Classification  Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapConCnt\" title=\"Slice CapConCnt: The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined]\nExample: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.\">property:CapConCnt</a><a name=\"ManufacturedItemDefinition.property.9\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Capsule Constituent Count</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapConCnt.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.8\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapConCnt.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.8\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Capsule Constituent Count</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapConCnt.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.7\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Quantity.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">System that defines coded unit form<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://unitsofmeasure.org</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Quantity.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Coded form of the unit<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">1</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:CapConCnt.value[x].value\">value</a><a name=\"ManufacturedItemDefinition.property.value_x_.value.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Numerical value (with implicit precision)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Schematic\" title=\"Slice Schematic: The pictorial representation of the drug product. [Source: SME Defined]\">property:Schematic</a><a name=\"ManufacturedItemDefinition.property.10\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Schematic<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Schematic.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.9\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Schematic.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.9\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Product Schematic</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Schematic.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.8\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-pqcmc-graphic-attachment.html\" title=\"Attachment\">GraphicAttachment</a>, <a href=\"StructureDefinition-pqcmc-pdf-attachment.html\" title=\"Attachment\">PDFAttachment</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:WgtTyp\" title=\"Slice WgtTyp: A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined]\nExample: Mass, Activity\">property:WgtTyp</a><a name=\"ManufacturedItemDefinition.property.11\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Weight Type</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:WgtTyp.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.10\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:WgtTyp.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.10\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Product Weight Type</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:WgtTyp.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.9\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-strength-type-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology\">Strength Type Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtNum\" title=\"Slice TotWgtNum: Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a tablet or a capsule\">property:TotWgtNum</a><a name=\"ManufacturedItemDefinition.property.12\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Total Weight Numeric Numerator</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtNum.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.11\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtNum.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.11\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Product Total Weight Numeric Numerator</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtNum.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.10\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-units-of-measure.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure\">Units Of Measure</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#extensible\" title=\"To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.\">extensible</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator\" title=\"A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined]\nNote: This is typically applicable to biologics.\">comparator</a><a name=\"ManufacturedItemDefinition.property.value_x_.comparator\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Total Weight Operator</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtDen\" title=\"Slice TotWgtDen: Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined]\nNote: For solid oral dose forms, by definition this is 1\">property:TotWgtDen</a><a name=\"ManufacturedItemDefinition.property.13\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Total Weight Numeric Denominator</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtDen.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.12\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtDen.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.12\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Product Total Weight Numeric Denominator</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtDen.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.11\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#SimpleQuantity\" title=\"Quantity\">SimpleQuantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-units-of-measure.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure\">Units Of Measure</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#extensible\" title=\"To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.\">extensible</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtDen.value[x].value\">value</a><a name=\"ManufacturedItemDefinition.property.value_x_.value.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Numerical value (with implicit precision)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtTxt\" title=\"Slice TotWgtTxt: A written description of the weight of the drug product. [Source: SME Defined]\nNote:ï¿½This is typically applicable to biologics\nExample: International Units for Enzymes\">property:TotWgtTxt</a><a name=\"ManufacturedItemDefinition.property.14\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Total Weight Textual</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtTxt.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.13\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtTxt.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.13\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Total Weight Textual</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:TotWgtTxt.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.12\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:QualStd\" title=\"Slice QualStd: The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard\">property:QualStd</a><a name=\"ManufacturedItemDefinition.property.15\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Quality Standard<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:QualStd.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.14\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:QualStd.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.14\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Quality Standard</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:QualStd.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.13\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-quality-benchmark-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology\">Quality Benchmark Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Sterile\" title=\"Slice Sterile\">property:Sterile</a><a name=\"ManufacturedItemDefinition.property.16\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Sterile Product Indicator</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1251.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Sterile.type\">type</a><a name=\"ManufacturedItemDefinition.property.type.15\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Sterile.type.text\">text</a><a name=\"ManufacturedItemDefinition.property.type.text.15\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">Sterile Product Indicator</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.property:Sterile.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.property.value_x_.14\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">A value for the characteristic</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component\">component</a><a name=\"ManufacturedItemDefinition.component\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-amount-ratio-or-quantity )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup</span><br/><span style=\"font-weight:bold\">cmc-amount-ratio-or-quantity: </span>The amount ratio extension and an amount with a non-percentage unit are mutually exclusive</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_modifier_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.modifierExtension\">Slices for modifierExtension</a><a name=\"ManufacturedItemDefinition.component.modifierExtension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">Slice: </span>Unordered, Open by value:url</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.modifierExtension:amountRatio\" title=\"Slice amountRatio\">modifierExtension:amountRatio</a><a name=\"ManufacturedItemDefinition.component.modifierExtension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-pq-amount-ratio.html\" title=\"Extension\">AmountRatio</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Amount Ratio</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.type\" title=\"Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]\nExample: Layer, Bead, Minitablet, Capsule Shell, Coating\">type</a><a name=\"ManufacturedItemDefinition.component.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Part Type</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.type.coding\">coding</a><a name=\"ManufacturedItemDefinition.component.type.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-product-part-type.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type\">Product Part Type Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.function\" title=\"The main purpose for the part in the dosage form. [Source: SME Defined]\nExample: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2\">function</a><a name=\"ManufacturedItemDefinition.component.function\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-codeable-concept-text-only.html\" title=\"CodeableConcept\">CodeableConceptTextOnly</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Part Function Description</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount\">Slices for amount</a><a name=\"ManufacturedItemDefinition.component.amount\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"opacity: 0.5; font-style: italic\">0</span><span style=\"font-style: italic\">..</span><span style=\"font-style: italic\">2</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5; font-style: italic\">The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Open by value:code</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:weight\" title=\"Slice weight\">amount:weight</a><a name=\"ManufacturedItemDefinition.component.amount.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:weight.value\" title=\"Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule\">value</a><a name=\"ManufacturedItemDefinition.component.amount.value\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Part Total Weight Numeric</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:weight.unit\">unit</a><a name=\"ManufacturedItemDefinition.component.amount.unit\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Part Total Weight Numeric UOM</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:weight.code\">code</a><a name=\"ManufacturedItemDefinition.component.amount.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Coded form of the unit</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-non-percentage-units.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units\">Non-Percentage Units</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:percent\" title=\"Slice percent\">amount:percent</a><a name=\"ManufacturedItemDefinition.component.amount.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:percent.value\" title=\"The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined]\nExample: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5\">value</a><a name=\"ManufacturedItemDefinition.component.amount.value.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Part Content Percent</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:percent.unit\" title=\"The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055]\nExample: mg\">unit</a><a name=\"ManufacturedItemDefinition.component.amount.unit.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Part Content Percent UOM</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.amount:percent.code\">code</a><a name=\"ManufacturedItemDefinition.component.amount.code.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Coded form of the unit</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-percentage-units.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units\">Percentage Units</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.constituent\" title=\"A classification that identifies the higher level purpose of that material. [Source: SME Defined]\nExample: Active Ingredient, Inactive Ingredient, Adjuvant.\">constituent</a><a name=\"ManufacturedItemDefinition.component.constituent\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-ingredient-functions, cmc-amount-ratio-or-quantity )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Product Part Ingredient Component Function Category<br/><span style=\"font-weight:bold\">cmc-ingredient-functions: </span>If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable.\nIf Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.<br/><span style=\"font-weight:bold\">cmc-amount-ratio-or-quantity: </span>The amount ratio extension and an amount with a non-percentage unit are mutually exclusive</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0113.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.constituent.extension\">Slices for extension</a><a name=\"ManufacturedItemDefinition.component.constituent.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">Slice: </span>Unordered, Open by value:url</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.constituent.extension:textualStrength\" title=\"Extension URL = http://hl7.org/fhir/StructureDefinition/originalText\">textualStrength</a><a name=\"ManufacturedItemDefinition.component.constituent.extension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">(Complex)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Original Text that represents the data as seen/selected/uttered originally</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"http://hl7.org/fhir/extensions/5.1.0/StructureDefinition-originalText.html\">http://hl7.org/fhir/StructureDefinition/originalText</a></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.constituent.extension:textualStrength.value[x]\">value[x]</a><a name=\"ManufacturedItemDefinition.component.constituent.extension.value_x_\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Textual Strength</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0113.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_modifier_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.constituent.modifierExtension\">Slices for modifierExtension</a><a name=\"ManufacturedItemDefinition.component.constituent.modifierExtension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><spa"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-product-part-definitions.html#ManufacturedItemDefinition.component.property:PPiD.type\">type</a><a name=\"ManufacturedItemDefinition.component.property.type.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013500.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "mustSupport" : false,
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.identifier",
        "path" : "ManufacturedItemDefinition.identifier",
        "short" : "Unique identifier",
        "definition" : "Unique identifier.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.identifier",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Identifier"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "w5",
            "map" : "FiveWs.class"
          },
          {
            "identity" : "idmp",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.status",
        "path" : "ManufacturedItemDefinition.status",
        "short" : "draft | active | retired | unknown",
        "definition" : "The status of this item. Enables tracking the life-cycle of the content.",
        "comment" : "Allows filtering of manufactured items that are appropriate for use versus not.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.status",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because applications should not use a retired {{title}} without due consideration",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "required",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.name",
        "path" : "ManufacturedItemDefinition.name",
        "short" : "Product Proprietary Name | Product Non-proprietary Name",
        "definition" : "Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. \nExample: Tylenol\n\nProduct Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.name",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "w5",
            "map" : "FiveWs.class"
          },
          {
            "identity" : "idmp",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.manufacturedDoseForm",
        "path" : "ManufacturedItemDefinition.manufacturedDoseForm",
        "short" : "Dose form as manufactured (before any necessary transformation)",
        "definition" : "Dose form as manufactured and before any transformation into the pharmaceutical product.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.manufacturedDoseForm",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Manufactured Dose Form"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.unitOfPresentation",
        "path" : "ManufacturedItemDefinition.unitOfPresentation",
        "short" : "The â€œreal-worldâ€ units in which the quantity of the item is described",
        "definition" : "The â€œreal-worldâ€ units in which the quantity of the manufactured item is described.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.unitOfPresentation",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "UnitOfPresentation"
            }
          ],
          "strength" : "example",
          "description" : "The presentation type in which an administrable medicinal product is given to a patient.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/unit-of-presentation"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Unit of Presentation"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.manufacturer",
        "path" : "ManufacturedItemDefinition.manufacturer",
        "short" : "Manufacturer of the item, one of several possible",
        "definition" : "Manufacturer of the item, one of several possible.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.manufacturer",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Organization"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Manufacturer / Establishment (Organisation)"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.marketingStatus",
        "path" : "ManufacturedItemDefinition.marketingStatus",
        "short" : "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated",
        "definition" : "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.marketingStatus",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "MarketingStatus"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.ingredient",
        "path" : "ManufacturedItemDefinition.ingredient",
        "short" : "The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource",
        "definition" : "The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.ingredient",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTSubstanceCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Ingredient (see also FHIR Ingredient resource)"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property",
        "path" : "ManufacturedItemDefinition.property",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.text"
            }
          ],
          "description" : "Slice based on value",
          "rules" : "closed"
        },
        "short" : "General characteristics of this item",
        "definition" : "General characteristics of this item.",
        "min" : 6,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          },
          {
            "code" : "Quantity"
          },
          {
            "code" : "date"
          },
          {
            "code" : "boolean"
          },
          {
            "code" : "markdown"
          },
          {
            "code" : "Attachment"
          },
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Binary"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "OvrRelsProf",
        "short" : "Product Overall Release Profile",
        "definition" : "The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids).\nFor example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the \"product overall release profile\" is \"ER\". [Source: SME Defined]",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Overall Release Profile",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "OvrRelsMech",
        "short" : "Product Overall Release Mechanism",
        "definition" : "The dosage form design used to achieve an ER release profile.  Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Overall Release Mechanism",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "CoatInd",
        "short" : "Product Coating Indicator",
        "definition" : "A property that identifies whether the drug product contains any coatings. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Coating Indicator",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "LayCnt",
        "short" : "Product Tablet Layer Count",
        "definition" : "The total number of layers in the tablet. [Source: SME Defined]\nNote: Non-layered tablets will be considered as one layer tablets.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Tablet Layer Count",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "patternQuantity" : {
          "system" : "http://unitsofmeasure.org",
          "code" : "1"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].id",
        "path" : "ManufacturedItemDefinition.property.value[x].id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].extension",
        "path" : "ManufacturedItemDefinition.property.value[x].extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].value",
        "path" : "ManufacturedItemDefinition.property.value[x].value",
        "short" : "Numerical value (with implicit precision)",
        "definition" : "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
        "comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
        "requirements" : "Precision is handled implicitly in almost all cases of measurement.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "decimal"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.2  / CQ - N/A"
          },
          {
            "identity" : "rim",
            "map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].comparator",
        "path" : "ManufacturedItemDefinition.property.value[x].comparator",
        "short" : "< | <= | >= | > | ad - how to understand the value",
        "definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
        "requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "QuantityComparator"
            }
          ],
          "strength" : "required",
          "description" : "How the Quantity should be understood and represented.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.1  / CQ.1"
          },
          {
            "identity" : "rim",
            "map" : "IVL properties"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].unit",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.value[x].unit",
        "short" : "Unit representation",
        "definition" : "A human-readable form of the unit.",
        "requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.unit",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.unit"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].system",
        "path" : "ManufacturedItemDefinition.property.value[x].system",
        "short" : "System that defines coded unit form",
        "definition" : "The identification of the system that provides the coded form of the unit.",
        "requirements" : "Need to know the system that defines the coded form of the unit.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "CO.codeSystem, PQ.translation.codeSystem"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].code",
        "path" : "ManufacturedItemDefinition.property.value[x].code",
        "short" : "Coded form of the unit",
        "definition" : "A computer processable form of the unit in some unit representation system.",
        "comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system.",
        "requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.code, MO.currency, PQ.translation.code"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "BeaTypCnt",
        "short" : "Tablet Bead Type Count",
        "definition" : "The total number of type of beads present in a tablet [Source: SME Defined]\nExample: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Tablet Bead Type Count",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "patternQuantity" : {
          "system" : "http://unitsofmeasure.org",
          "code" : "1"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].id",
        "path" : "ManufacturedItemDefinition.property.value[x].id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].extension",
        "path" : "ManufacturedItemDefinition.property.value[x].extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].value",
        "path" : "ManufacturedItemDefinition.property.value[x].value",
        "short" : "Numerical value (with implicit precision)",
        "definition" : "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
        "comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
        "requirements" : "Precision is handled implicitly in almost all cases of measurement.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "decimal"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.2  / CQ - N/A"
          },
          {
            "identity" : "rim",
            "map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator",
        "path" : "ManufacturedItemDefinition.property.value[x].comparator",
        "short" : "< | <= | >= | > | ad - how to understand the value",
        "definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
        "requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "QuantityComparator"
            }
          ],
          "strength" : "required",
          "description" : "How the Quantity should be understood and represented.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.1  / CQ.1"
          },
          {
            "identity" : "rim",
            "map" : "IVL properties"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].unit",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.value[x].unit",
        "short" : "Unit representation",
        "definition" : "A human-readable form of the unit.",
        "requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.unit",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.unit"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].system",
        "path" : "ManufacturedItemDefinition.property.value[x].system",
        "short" : "System that defines coded unit form",
        "definition" : "The identification of the system that provides the coded form of the unit.",
        "requirements" : "Need to know the system that defines the coded form of the unit.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "CO.codeSystem, PQ.translation.codeSystem"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].code",
        "path" : "ManufacturedItemDefinition.property.value[x].code",
        "short" : "Coded form of the unit",
        "definition" : "A computer processable form of the unit in some unit representation system.",
        "comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system.",
        "requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.code, MO.currency, PQ.translation.code"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "CapClass",
        "short" : "Capsule Shell Part Classification Category",
        "definition" : "Categorization of the capsule shell based on factors such as the shellâ€™s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Capsule Classification Category",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "CapConCnt",
        "short" : "Product Capsule Constituent Count",
        "definition" : "The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined]\nExample: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Capsule Constituent Count",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "patternQuantity" : {
          "system" : "http://unitsofmeasure.org",
          "code" : "1"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].id",
        "path" : "ManufacturedItemDefinition.property.value[x].id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].extension",
        "path" : "ManufacturedItemDefinition.property.value[x].extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].value",
        "path" : "ManufacturedItemDefinition.property.value[x].value",
        "short" : "Numerical value (with implicit precision)",
        "definition" : "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
        "comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
        "requirements" : "Precision is handled implicitly in almost all cases of measurement.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "decimal"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.2  / CQ - N/A"
          },
          {
            "identity" : "rim",
            "map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].comparator",
        "path" : "ManufacturedItemDefinition.property.value[x].comparator",
        "short" : "< | <= | >= | > | ad - how to understand the value",
        "definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
        "requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "QuantityComparator"
            }
          ],
          "strength" : "required",
          "description" : "How the Quantity should be understood and represented.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.1  / CQ.1"
          },
          {
            "identity" : "rim",
            "map" : "IVL properties"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].unit",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.value[x].unit",
        "short" : "Unit representation",
        "definition" : "A human-readable form of the unit.",
        "requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.unit",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.unit"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].system",
        "path" : "ManufacturedItemDefinition.property.value[x].system",
        "short" : "System that defines coded unit form",
        "definition" : "The identification of the system that provides the coded form of the unit.",
        "requirements" : "Need to know the system that defines the coded form of the unit.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "CO.codeSystem, PQ.translation.codeSystem"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].code",
        "path" : "ManufacturedItemDefinition.property.value[x].code",
        "short" : "Coded form of the unit",
        "definition" : "A computer processable form of the unit in some unit representation system.",
        "comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system.",
        "requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.code, MO.currency, PQ.translation.code"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "Schematic",
        "short" : "Product Schematic",
        "definition" : "The pictorial representation of the drug product. [Source: SME Defined]",
        "min" : 1,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type&
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:WgtTyp.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the s "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.id",
        "path" : "ManufacturedItemDefinition.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.extension",
        "path" : "ManufacturedItemDefinition.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.modifierExtension",
        "path" : "ManufacturedItemDefinition.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.type.id",
        "path" : "ManufacturedItemDefinition.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.type.extension",
        "path" : "ManufacturedItemDefinition.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.type.coding",
        "path" : "ManufacturedItemDefinition.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Sterile Product Indicator",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component",
        "path" : "ManufacturedItemDefinition.component",
        "short" : "Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup",
        "definition" : "Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup.",
        "min" : 1,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.component",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "cmc-amount-ratio-or-quantity",
            "severity" : "error",
            "human" : "The amount ratio extension and an amount with a non-percentage unit are mutually exclusive",
            "expression" : "defineVariable('system','http://unitsofmeasure.org').select(\n  modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio')\n  .union(\n    amount.where(\n        system = %system and \n        code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units')\n    )\n  ).count() = 1\n)",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Manufactured Item.Physical Characteristics"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.id",
        "path" : "ManufacturedItemDefinition.component.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.extension",
        "path" : "ManufacturedItemDefinition.component.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.modifierExtension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.modifierExtension:amountRatio",
        "path" : "ManufacturedItemDefinition.component.modifierExtension",
        "sliceName" : "amountRatio",
        "short" : "Amount Ratio",
        "definition" : "represent an amount as a ratio in ManufacturedItemDefinition",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "mustSupport" : true,
        "isModifier" : true,
        "isModifierReason" : "the PQCMC use Case requires ingredient and part amounts be accepted as either quantities or ratios. When present, an amount representing anything but the percentage cannot be present"
      },
      {
        "id" : "ManufacturedItemDefinition.component.type",
        "path" : "ManufacturedItemDefinition.component.type",
        "short" : "Product Part Type",
        "definition" : "Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]\nExample: Layer, Bead, Minitablet, Capsule Shell, Coating",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.type.id",
        "path" : "ManufacturedItemDefinition.component.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.type.extension",
        "path" : "ManufacturedItemDefinition.component.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.type.coding",
        "path" : "ManufacturedItemDefinition.component.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.function",
        "path" : "ManufacturedItemDefinition.component.function",
        "short" : "Product Part Function Description",
        "definition" : "The main purpose for the part in the dosage form. [Source: SME Defined]\nExample: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.function",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount",
        "path" : "ManufacturedItemDefinition.component.amount",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "code"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "short" : "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)",
        "definition" : "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).",
        "min" : 0,
        "max" : "2",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.amount",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight",
        "path" : "ManufacturedItemDefinition.component.amount",
        "sliceName" : "weight",
        "short" : "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)",
        "definition" : "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.amount",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.id",
        "path" : "ManufacturedItemDefinition.component.amount.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.extension",
        "path" : "ManufacturedItemDefinition.component.amount.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.value",
        "path" : "ManufacturedItemDefinition.component.amount.value",
        "short" : "Product Part Total Weight Numeric",
        "definition" : "Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule",
        "comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
        "requirements" : "Precision is handled implicitly in almost all cases of measurement.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "decimal"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.2  / CQ - N/A"
          },
          {
            "identity" : "rim",
            "map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.comparator",
        "path" : "ManufacturedItemDefinition.component.amount.comparator",
        "short" : "< | <= | >= | > | ad - how to understand the value",
        "definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
        "requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "QuantityComparator"
            }
          ],
          "strength" : "required",
          "description" : "How the Quantity should be understood and represented.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.1  / CQ.1"
          },
          {
            "identity" : "rim",
            "map" : "IVL properties"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.unit",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.amount.unit",
        "short" : "Product Part Total Weight Numeric UOM",
        "definition" : "A human-readable form of the unit.",
        "requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.unit",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.unit"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.system",
        "path" : "ManufacturedItemDefinition.component.amount.system",
        "short" : "System that defines coded unit form",
        "definition" : "The identification of the system that provides the coded form of the unit.",
        "requirements" : "Need to know the system that defines the coded form of the unit.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "CO.codeSystem, PQ.translation.codeSystem"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.code",
        "path" : "ManufacturedItemDefinition.component.amount.code",
        "short" : "Coded form of the unit",
        "definition" : "A computer processable form of the unit in some unit representation system.",
        "comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system.",
        "requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.code, MO.currency, PQ.translation.code"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent",
        "path" : "ManufacturedItemDefinition.component.amount",
        "sliceName" : "percent",
        "short" : "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)",
        "definition" : "The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.amount",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.id",
        "path" : "ManufacturedItemDefinition.component.amount.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.extension",
        "path" : "ManufacturedItemDefinition.component.amount.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.value",
        "path" : "ManufacturedItemDefinition.component.amount.value",
        "short" : "Product Part Content Percent",
        "definition" : "The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined]\nExample: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5",
        "comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
        "requirements" : "Precision is handled implicitly in almost all cases of measurement.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "decimal"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.2  / CQ - N/A"
          },
          {
            "identity" : "rim",
            "map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.comparator",
        "path" : "ManufacturedItemDefinition.component.amount.comparator",
        "short" : "< | <= | >= | > | ad - how to understand the value",
        "definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
        "requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "QuantityComparator"
            }
          ],
          "strength" : "required",
          "description" : "How the Quantity should be understood and represented.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.1  / CQ.1"
          },
          {
            "identity" : "rim",
            "map" : "IVL properties"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.unit",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.amount.unit",
        "short" : "Product Part Content Percent UOM",
        "definition" : "The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055]\nExample: mg",
        "requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.unit",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.unit"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.system",
        "path" : "ManufacturedItemDefinition.component.amount.system",
        "short" : "System that defines coded unit form",
        "definition" : "The identification of the system that provides the coded form of the unit.",
        "requirements" : "Need to know the system that defines the coded form of the unit.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "CO.codeSystem, PQ.translation.codeSystem"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.code",
        "path" : "ManufacturedItemDefinition.component.amount.code",
        "short" : "Coded form of the unit",
        "definition" : "A computer processable form of the unit in some unit representation system.",
        "comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system.",
        "requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.code, MO.currency, PQ.translation.code"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent",
        "path" : "ManufacturedItemDefinition.component.constituent",
        "short" : "Product Part Ingredient Component Function Category",
        "definition" : "A classification that identifies the higher level purpose of that material. [Source: SME Defined]\nExample: Active Ingredient, Inactive Ingredient, Adjuvant.",
        "min" : 1,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "cmc-ingredient-functions",
            "severity" : "error",
            "human" : "If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable.\nIf Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.",
            "expression" : "function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-amount-ratio-or-quantity",
            "severity" : "error",
            "human" : "The amount ratio extension and an amount with a non-percentage unit are mutually exclusive",
            "expression" : "defineVariable('system','http://unitsofmeasure.org').select(\n  modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio')\n  .union(\n    amount.where(\n        system = %system and \n        code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units')\n    )\n  ).count() = 1\n)",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.id",
        "path" : "ManufacturedItemDefinition.component.constituent.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension",
        "path" : "ManufacturedItemDefinition.component.constituent.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension:textualStrength",
        "path" : "ManufacturedItemDefinition.component.constituent.extension",
        "sliceName" : "textualStrength",
        "short" : "Original Text that represents the data as seen/selected/uttered originally",
        "definition" : "A human language representation of the concept (resource/element) as seen/selected/uttered by the user who entered the data and/or which represents the full intended meaning of the user. This can be provided either directly as text, or as a url that is a reference to a portion of the narrative of a resource ([DomainResource.text](http://hl7.org/fhir/R5/narrative.html) or [Composition.section.text](http://hl7.org/fhir/R5/composition-definitions.html#Composition.section.text)). When it a url, the value should end with a #{id} where the id identifies a specific portion of the referenced content (via an XHTML id attribute).",
        "comment" : "For whatever reason, the comments for the Original Text extension has a link that doesn't resolve! Overwriting it with this text resolves the IG error",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              "http://hl7.org/fhir/StructureDefinition/originalText"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension:textualStrength.id",
        "path" : "ManufacturedItemDefinition.component.constituent.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension:textualStrength.extension",
        "path" : "ManufacturedItemDefinition.component.constituent.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension:textualStrength.url",
        "path" : "ManufacturedItemDefinition.component.constituent.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "http://hl7.org/fhir/StructureDefinition/originalText",
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension:textualStrength.value[x]",
        "path" : "ManufacturedItemDefinition.component.constituent.extension.value[x]",
        "short" : "Textual Strength",
        "definition" : "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.constituent.modifierExtension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.modifierExtension:amountRatio",
        "path" : "ManufacturedItemDefinition.component.constituent.modifierExtension",
        "sliceName" : "amountRatio",
        "short" : "Amount Ratio",
        "definition" : "represent an amount as a ratio in ManufacturedItemDefinition",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "mustSupport" : true,
        "isModifier" : true,
        "isModifierReason" : "the PQCMC use Case requires ingredient and part amounts be accepted as either quantities or ratios. When present, an amount representing anything but the percentage cannot be present"
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount",
        "path" : "ManufacturedItemDefinition.component.constituent.amount",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "code"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "short" : "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)",
        "definition" : "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).",
        "min" : 1,
        "max" : "2",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.amount",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight",
        "path" : "ManufacturedItemDefinition.component.constituent.amount",
        "sliceName" : "weight",
        "short" : "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)",
        "definition" : "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.amount",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.id",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.extension",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.value",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.value",
        "short" : "Product Part Ingredient Amount Numeric",
        "definition" : "Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined]\nNote: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule\nNote: Amount can also be referred to as potency in biologics and other products.",
        "comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
        "requirements" : "Precision is handled implicitly in almost all cases of measurement.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "decimal"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.2  / CQ - N/A"
          },
          {
            "identity" : "rim",
            "map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.comparator",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.comparator",
        "short" : "< | <= | >= | > | ad - how to understand the value",
        "definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
        "requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "QuantityComparator"
            }
          ],
          "strength" : "required",
          "description" : "How the Quantity should be understood and represented.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.1  / CQ.1"
          },
          {
            "identity" : "rim",
            "map" : "IVL properties"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.unit",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.constituent.amount.unit",
        "short" : "Product Part Ingredient Amount Numeric UOM",
        "definition" : "The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]",
        "requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.unit",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.unit"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.system",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.system",
        "short" : "System that defines coded unit form",
        "definition" : "The identification of the system that provides the coded form of the unit.",
        "requirements" : "Need to know the system that defines the coded form of the unit.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "CO.codeSystem, PQ.translation.codeSystem"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.code",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.code",
        "short" : "Coded form of the unit",
        "definition" : "A computer processable form of the unit in some unit representation system.",
        "comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system.",
        "requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.code, MO.currency, PQ.translation.code"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent",
        "path" : "ManufacturedItemDefinition.component.constituent.amount",
        "sliceName" : "percent",
        "short" : "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)",
        "definition" : "The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.amount",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.id",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.extension",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.value",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.value",
        "short" : "Product Part Ingredient Content Percent",
        "definition" : "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
        "comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
        "requirements" : "Precision is handled implicitly in almost all cases of measurement.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "decimal"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.2  / CQ - N/A"
          },
          {
            "identity" : "rim",
            "map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.comparator",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.comparator",
        "short" : "< | <= | >= | > | ad - how to understand the value",
        "definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
        "requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "QuantityComparator"
            }
          ],
          "strength" : "required",
          "description" : "How the Quantity should be understood and represented.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "SN.1  / CQ.1"
          },
          {
            "identity" : "rim",
            "map" : "IVL properties"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.unit",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.constituent.amount.unit",
        "short" : "Product Part Ingredient Content Percent UOM",
        "definition" : "A human-readable form of the unit.",
        "requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Quantity.unit",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.unit"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.system",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.system",
        "short" : "System that defines coded unit form",
        "definition" : "The identification of the system that provides the coded form of the unit.",
        "requirements" : "Need to know the system that defines the coded form of the unit.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "CO.codeSystem, PQ.translation.codeSystem"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.code",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.code",
        "short" : "Coded form of the unit",
        "definition" : "A computer processable form of the unit in some unit representation system.",
        "comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system.",
        "requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Quantity.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "qty-3"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "(see OBX.6 etc.) / CQ.2"
          },
          {
            "identity" : "rim",
            "map" : "PQ.code, MO.currency, PQ.translation.code"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location",
        "path" : "ManufacturedItemDefinition.component.constituent.location",
        "short" : "Product Part Ingredient Physical Location",
        "definition" : "Identifies where the ingredient physically resides within the product part. [Source: SME Defined]\nExamples: Intragranular, Extra granular, Blend",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.location",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location.id",
        "path" : "ManufacturedItemDefinition.component.constituent.location.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location.extension",
        "path" : "ManufacturedItemDefinition.component.constituent.location.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location.coding",
        "path" : "ManufacturedItemDefinition.component.constituent.location.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.constituent.location.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.function",
        "path" : "ManufacturedItemDefinition.component.constituent.function",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "$this"
            }
          ],
          "description" : "Slice on the function coding",
          "rules" : "closed"
        },
        "short" : "The function of this constituent within the component e.g. binder",
        "definition" : "The function of this constituent within the component e.g. binder.",
        "min" : 1,
        "max" : "2",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.function",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.function:Category",
        "path" : "ManufacturedItemDefinition.component.constituent.function",
        "sliceName" : "Category",
        "short" : "The function of this constituent within the component e.g. binder",
        "definition" : "The function of this constituent within the component e.g. binder.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.function",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.function:Function",
        "path" : "ManufacturedItemDefinition.component.constituent.function",
        "sliceName" : "Function",
        "short" : "Product Part Ingredient Function",
        "definition" : "A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined]\nExamples: Filler, Surfactant",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.function",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.hasIngredient",
        "path" : "ManufacturedItemDefinition.component.constituent.hasIngredient",
        "short" : "The ingredient that is the constituent of the given component",
        "definition" : "The ingredient that is the constituent of the given component.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.constituent.hasIngredient",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableReference",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference"
            ],
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component"
            ],
            "aggregation" : [
              "bundled"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property",
        "path" : "ManufacturedItemDefinition.component.property",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.text"
            }
          ],
          "description" : "Slice based on value",
          "rules" : "closed"
        },
        "short" : "General characteristics of this component",
        "definition" : "General characteristics of this component.",
        "min" : 2,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          },
          {
            "code" : "Quantity"
          },
          {
            "code" : "date"
          },
          {
            "code" : "boolean"
          },
          {
            "code" : "markdown"
          },
          {
            "code" : "Attachment"
          },
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Binary"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "PPiD",
        "short" : "Product Part Identifier",
        "definition" : "A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined]\nExamples: 1, A1, Red bead, Blue minitablet",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Part Identifier",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "PPiDref",
        "short" : "Product Part Identifier Reference",
        "definition" : "Identifies the parent or outer-level product part. [Source: SME Defined]\nExample: A bead (Product Part Identifier = â€œB1â€) has a seal coating (Product Part Identifier = â€œSCoatâ€) and is contained in a Hard HPMC capsule shell (Product Part Identifier â€œCap Shellâ€). For the seal coating, Product Part Identifier Reference = â€œB1â€, because the seal coat is applied to the bead.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Part Identifier Reference",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "RelsProf",
        "short" : "Product Part Release Profile",
        "definition" : "The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Part Release Profile",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "RelsMech",
        "short" : "Product Part Release Mechanism",
        "definition" : "The method employed to realize the specified part release profile. [Source: SME Defined] \nExample: matrix or reservoir",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Part Release Mechanism",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "CoatPurpose",
        "short" : "Coating Product Part Purpose",
        "definition" : "The reason the coating or covering was added. [Source: SME Defined]\nExamples: rate-controlling, color, release type, protective, taste masking.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Coating Product Part Purpose",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "Color",
        "short" : "Product Part Color Description",
        "definition" : "The hue or the tint of the drug product part. [Source: SME Defined]\nExamples: yellow, pink, blue, pale yellow.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Part Color Description",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "AddInfo",
        "short" : "Product Part Additional Information",
        "definition" : "A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.\nImplementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.property",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.id",
        "path" : "ManufacturedItemDefinition.component.property.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.extension",
        "path" : "ManufacturedItemDefinition.component.property.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.property.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "short" : "A code expressing the type of characteristic",
        "definition" : "A code expressing the type of characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SNOMEDCTCharacteristicCodes"
            }
          ],
          "strength" : "example",
          "description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
        },
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, all attributes"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.type.id",
        "path" : "ManufacturedItemDefinition.component.property.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.type.extension",
        "path" : "ManufacturedItemDefinition.component.property.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.type.coding",
        "path" : "ManufacturedItemDefinition.component.property.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "patternString" : "Product Part Additional Information",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "short" : "A value for the characteristic",
        "definition" : "A value for the characteristic.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ManufacturedItemDefinition.property.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "markdown"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp",
            "map" : "Physical Characteristics, attribute's value"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.component",
        "path" : "ManufacturedItemDefinition.component.component",
        "short" : "A component that this component contains or is made from",
        "definition" : "A component that this component contains or is made from.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "ManufacturedItemDefinition.component.component",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      }
    ]
  },
  "differential" : {
    "element" : [
      {
        "id" : "ManufacturedItemDefinition",
        "path" : "ManufacturedItemDefinition",
        "constraint" : [
          {
            "key" : "cmc-capsule-count-required",
            "severity" : "error",
            "human" : "Capsule constituent count is required when the dosage form is 'Capsule'",
            "expression" : "defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(\n    manufacturedDoseForm.coding.exists(system = %system and code = 'C154433')\nimplies property.where(type.text = 'Capsule Constituent Count').exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-arbitrary-unit-text-required",
            "severity" : "error",
            "human" : "BR â€“ Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual",
            "expression" : "defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(\n    property.where(\n    type.coding.exists(\n        system = %system and (\n            code = 'TotWgtNum' or \n            code = 'TotWgtDen'\n        )\n    ) and\n    value.exists(system = %system and code = 'C75765')\n).exists() implies property.where(\n    type = 'Total Weight Textual'\n).exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-coating-indication-required",
            "severity" : "error",
            "human" : "Coating indication is required when the dosage form is a tablet, lozenge or capsule",
            "expression" : "defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(\n    manufacturedDoseForm.coding.exists(system = %system and (\n    code = 'C154605' or\n    code = 'C154433' or\n    code = 'C154554'\n))\nimplies property.where(type.text = 'Coating Indicator').exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-tablet-layer-count-required",
            "severity" : "error",
            "human" : "Tablet layer count is required when the dosage form is a tablet",
            "expression" : "defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(\n    manufacturedDoseForm.coding.exists(\n    system = %system and\n    code = 'C154605'\n) implies property.where(\n    type.text = 'Tablet Layer Count'\n).exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-tablet-bead-count-required",
            "severity" : "error",
            "human" : "Tablet bead count is required when the dosage form is a tablet",
            "expression" : "defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists(\n    system = %system and\n    code = 'C154605'\n) implies property.where(\n    type.text = 'Tablet Bead Type Count'\n).exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-capsule-classification-required",
            "severity" : "error",
            "human" : "when the the dosage form is 'capsule' and a 'capsule shell' part\nexists, a capsule shell part classification is mandatory",
            "expression" : "defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists(\n    system = %system and\n    code = 'C154433'\n) and component.type.coding.exists(\n    system = %system and\n    code = 'C203897'\n) implies property.where(\n    type.text = 'Capsule Classification Category'\n).exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-component-id-ref",
            "severity" : "error",
            "human" : "If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself",
            "expression" : "defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(\n  component.select(\n    property.where(\n      type.text = 'Product Part Identifier Reference'\n    ).select(value)\n  ).all(\n    text in %context.component.select(\n      property.where(\n        type.text = 'Product Part Identifier'\n      ).select(value.text)\n    )\n  ) and component.where(\n    property.where(\n      type.text = 'Product Part Identifier Reference'\n    ).select(value.text) =\n    property.where(\n      type.text = 'Product Part Identifier'\n    ).select(value.text)\n  ).exists().not()\n)",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.identifier",
        "path" : "ManufacturedItemDefinition.identifier",
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.status",
        "path" : "ManufacturedItemDefinition.status",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.name",
        "path" : "ManufacturedItemDefinition.name",
        "short" : "Product Proprietary Name | Product Non-proprietary Name",
        "definition" : "Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. \nExample: Tylenol\n\nProduct Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.manufacturedDoseForm",
        "path" : "ManufacturedItemDefinition.manufacturedDoseForm",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property",
        "path" : "ManufacturedItemDefinition.property",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.text"
            }
          ],
          "description" : "Slice based on value",
          "rules" : "closed"
        },
        "min" : 6,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property.type",
        "path" : "ManufacturedItemDefinition.property.type",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "OvrRelsProf",
        "short" : "Product Overall Release Profile",
        "definition" : "The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids).\nFor example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the \"product overall release profile\" is \"ER\". [Source: SME Defined]",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Product Overall Release Profile"
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsProf.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "OvrRelsMech",
        "short" : "Product Overall Release Mechanism",
        "definition" : "The dosage form design used to achieve an ER release profile.  Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Product Overall Release Mechanism"
      },
      {
        "id" : "ManufacturedItemDefinition.property:OvrRelsMech.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "CoatInd",
        "short" : "Product Coating Indicator",
        "definition" : "A property that identifies whether the drug product contains any coatings. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Coating Indicator"
      },
      {
        "id" : "ManufacturedItemDefinition.property:CoatInd.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "LayCnt",
        "short" : "Product Tablet Layer Count",
        "definition" : "The total number of layers in the tablet. [Source: SME Defined]\nNote: Non-layered tablets will be considered as one layer tablets.",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Tablet Layer Count"
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "patternQuantity" : {
          "system" : "http://unitsofmeasure.org",
          "code" : "1"
        },
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:LayCnt.value[x].value",
        "path" : "ManufacturedItemDefinition.property.value[x].value",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "BeaTypCnt",
        "short" : "Tablet Bead Type Count",
        "definition" : "The total number of type of beads present in a tablet [Source: SME Defined]\nExample: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Tablet Bead Type Count"
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "patternQuantity" : {
          "system" : "http://unitsofmeasure.org",
          "code" : "1"
        },
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:BeaTypCnt.value[x].value",
        "path" : "ManufacturedItemDefinition.property.value[x].value",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "CapClass",
        "short" : "Capsule Shell Part Classification Category",
        "definition" : "Categorization of the capsule shell based on factors such as the shellâ€™s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Capsule Classification Category"
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapClass.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "CapConCnt",
        "short" : "Product Capsule Constituent Count",
        "definition" : "The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined]\nExample: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Capsule Constituent Count"
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "patternQuantity" : {
          "system" : "http://unitsofmeasure.org",
          "code" : "1"
        },
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:CapConCnt.value[x].value",
        "path" : "ManufacturedItemDefinition.property.value[x].value",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "Schematic",
        "short" : "Product Schematic",
        "definition" : "The pictorial representation of the drug product. [Source: SME Defined]",
        "min" : 1,
        "max" : "*",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Product Schematic"
      },
      {
        "id" : "ManufacturedItemDefinition.property:Schematic.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "Attachment",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment",
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-pdf-attachment"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:WgtTyp",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "WgtTyp",
        "short" : "Product Weight Type",
        "definition" : "A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined]\nExample: Mass, Activity",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:WgtTyp.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Product Weight Type"
      },
      {
        "id" : "ManufacturedItemDefinition.property:WgtTyp.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtNum",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "TotWgtNum",
        "short" : "Product Total Weight Numeric Numerator",
        "definition" : "Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a tablet or a capsule",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtNum.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Product Total Weight Numeric Numerator"
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtNum.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "Quantity"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "extensible",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator",
        "path" : "ManufacturedItemDefinition.property.value[x].comparator",
        "short" : "Product Total Weight Operator",
        "definition" : "A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined]\nNote: This is typically applicable to biologics.",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtDen",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "TotWgtDen",
        "short" : "Product Total Weight Numeric Denominator",
        "definition" : "Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined]\nNote: For solid oral dose forms, by definition this is 1",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtDen.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Product Total Weight Numeric Denominator"
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtDen.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "Quantity",
            "profile" : [
              "http://hl7.org/fhir/StructureDefinition/SimpleQuantity"
            ]
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "extensible",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtDen.value[x].value",
        "path" : "ManufacturedItemDefinition.property.value[x].value",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtTxt",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "TotWgtTxt",
        "short" : "Product Total Weight Textual",
        "definition" : "A written description of the weight of the drug product. [Source: SME Defined]\nNote:ï¿½This is typically applicable to biologics\nExample: International Units for Enzymes",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtTxt.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Total Weight Textual"
      },
      {
        "id" : "ManufacturedItemDefinition.property:TotWgtTxt.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "markdown"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:QualStd",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "QualStd",
        "short" : "Product Quality Standard",
        "definition" : "The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard",
        "min" : 1,
        "max" : "*",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:QualStd.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Quality Standard"
      },
      {
        "id" : "ManufacturedItemDefinition.property:QualStd.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile",
        "path" : "ManufacturedItemDefinition.property",
        "sliceName" : "Sterile",
        "short" : "Sterile Product Indicator",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.type.text",
        "path" : "ManufacturedItemDefinition.property.type.text",
        "patternString" : "Sterile Product Indicator"
      },
      {
        "id" : "ManufacturedItemDefinition.property:Sterile.value[x]",
        "path" : "ManufacturedItemDefinition.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component",
        "path" : "ManufacturedItemDefinition.component",
        "min" : 1,
        "constraint" : [
          {
            "key" : "cmc-amount-ratio-or-quantity",
            "severity" : "error",
            "human" : "The amount ratio extension and an amount with a non-percentage unit are mutually exclusive",
            "expression" : "defineVariable('system','http://unitsofmeasure.org').select(\n  modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio')\n  .union(\n    amount.where(\n        system = %system and \n        code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units')\n    )\n  ).count() = 1\n)",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.modifierExtension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.modifierExtension:amountRatio",
        "path" : "ManufacturedItemDefinition.component.modifierExtension",
        "sliceName" : "amountRatio",
        "min" : 0,
        "max" : "1",
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.type",
        "path" : "ManufacturedItemDefinition.component.type",
        "short" : "Product Part Type",
        "definition" : "Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]\nExample: Layer, Bead, Minitablet, Capsule Shell, Coating",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.type.coding",
        "path" : "ManufacturedItemDefinition.component.type.coding",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.function",
        "path" : "ManufacturedItemDefinition.component.function",
        "short" : "Product Part Function Description",
        "definition" : "The main purpose for the part in the dosage form. [Source: SME Defined]\nExample: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2",
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount",
        "path" : "ManufacturedItemDefinition.component.amount",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "code"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "max" : "2",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight",
        "path" : "ManufacturedItemDefinition.component.amount",
        "sliceName" : "weight",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.value",
        "path" : "ManufacturedItemDefinition.component.amount.value",
        "short" : "Product Part Total Weight Numeric",
        "definition" : "Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined]\nNote: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.unit",
        "path" : "ManufacturedItemDefinition.component.amount.unit",
        "short" : "Product Part Total Weight Numeric UOM",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:weight.code",
        "path" : "ManufacturedItemDefinition.component.amount.code",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent",
        "path" : "ManufacturedItemDefinition.component.amount",
        "sliceName" : "percent",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.value",
        "path" : "ManufacturedItemDefinition.component.amount.value",
        "short" : "Product Part Content Percent",
        "definition" : "The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined]\nExample: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.unit",
        "path" : "ManufacturedItemDefinition.component.amount.unit",
        "short" : "Product Part Content Percent UOM",
        "definition" : "The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055]\nExample: mg",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.amount:percent.code",
        "path" : "ManufacturedItemDefinition.component.amount.code",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent",
        "path" : "ManufacturedItemDefinition.component.constituent",
        "short" : "Product Part Ingredient Component Function Category",
        "definition" : "A classification that identifies the higher level purpose of that material. [Source: SME Defined]\nExample: Active Ingredient, Inactive Ingredient, Adjuvant.",
        "min" : 1,
        "constraint" : [
          {
            "key" : "cmc-ingredient-functions",
            "severity" : "error",
            "human" : "If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable.\nIf Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.",
            "expression" : "function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          },
          {
            "key" : "cmc-amount-ratio-or-quantity",
            "severity" : "error",
            "human" : "The amount ratio extension and an amount with a non-percentage unit are mutually exclusive",
            "expression" : "defineVariable('system','http://unitsofmeasure.org').select(\n  modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio')\n  .union(\n    amount.where(\n        system = %system and \n        code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units')\n    )\n  ).count() = 1\n)",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension",
        "path" : "ManufacturedItemDefinition.component.constituent.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension:textualStrength",
        "path" : "ManufacturedItemDefinition.component.constituent.extension",
        "sliceName" : "textualStrength",
        "comment" : "For whatever reason, the comments for the Original Text extension has a link that doesn't resolve! Overwriting it with this text resolves the IG error",
        "min" : 0,
        "max" : "1",
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              "http://hl7.org/fhir/StructureDefinition/originalText"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.extension:textualStrength.value[x]",
        "path" : "ManufacturedItemDefinition.component.constituent.extension.value[x]",
        "short" : "Textual Strength",
        "type" : [
          {
            "code" : "string"
          }
        ]
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.modifierExtension",
        "path" : "ManufacturedItemDefinition.component.constituent.modifierExtension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.modifierExtension:amountRatio",
        "path" : "ManufacturedItemDefinition.component.constituent.modifierExtension",
        "sliceName" : "amountRatio",
        "min" : 0,
        "max" : "1",
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount",
        "path" : "ManufacturedItemDefinition.component.constituent.amount",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "code"
            }
          ],
          "ordered" : false,
          "rules" : "open"
        },
        "min" : 1,
        "max" : "2",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight",
        "path" : "ManufacturedItemDefinition.component.constituent.amount",
        "sliceName" : "weight",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.value",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.value",
        "short" : "Product Part Ingredient Amount Numeric",
        "definition" : "Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined]\nNote: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule\nNote: Amount can also be referred to as potency in biologics and other products.",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.unit",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.unit",
        "short" : "Product Part Ingredient Amount Numeric UOM",
        "definition" : "The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:weight.code",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.code",
        "min" : 1,
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent",
        "path" : "ManufacturedItemDefinition.component.constituent.amount",
        "sliceName" : "percent",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.value",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.value",
        "short" : "Product Part Ingredient Content Percent",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.unit",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.unit",
        "short" : "Product Part Ingredient Content Percent UOM",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.amount:percent.code",
        "path" : "ManufacturedItemDefinition.component.constituent.amount.code",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location",
        "path" : "ManufacturedItemDefinition.component.constituent.location",
        "short" : "Product Part Ingredient Physical Location",
        "definition" : "Identifies where the ingredient physically resides within the product part. [Source: SME Defined]\nExamples: Intragranular, Extra granular, Blend",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location.coding",
        "path" : "ManufacturedItemDefinition.component.constituent.location.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.location.text",
        "path" : "ManufacturedItemDefinition.component.constituent.location.text",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.function",
        "path" : "ManufacturedItemDefinition.component.constituent.function",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "$this"
            }
          ],
          "description" : "Slice on the function coding",
          "rules" : "closed"
        },
        "min" : 1,
        "max" : "2",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.function:Category",
        "path" : "ManufacturedItemDefinition.component.constituent.function",
        "sliceName" : "Category",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.function:Function",
        "path" : "ManufacturedItemDefinition.component.constituent.function",
        "sliceName" : "Function",
        "short" : "Product Part Ingredient Function",
        "definition" : "A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined]\nExamples: Filler, Surfactant",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.constituent.hasIngredient",
        "path" : "ManufacturedItemDefinition.component.constituent.hasIngredient",
        "min" : 1,
        "max" : "1",
        "type" : [
          {
            "code" : "CodeableReference",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference"
            ],
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component"
            ],
            "aggregation" : [
              "bundled"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property",
        "path" : "ManufacturedItemDefinition.component.property",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.text"
            }
          ],
          "description" : "Slice based on value",
          "rules" : "closed"
        },
        "min" : 2,
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.type",
        "path" : "ManufacturedItemDefinition.component.property.type",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "PPiD",
        "short" : "Product Part Identifier",
        "definition" : "A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined]\nExamples: 1, A1, Red bead, Blue minitablet",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "patternString" : "Product Part Identifier"
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiD.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "PPiDref",
        "short" : "Product Part Identifier Reference",
        "definition" : "Identifies the parent or outer-level product part. [Source: SME Defined]\nExample: A bead (Product Part Identifier = â€œB1â€) has a seal coating (Product Part Identifier = â€œSCoatâ€) and is contained in a Hard HPMC capsule shell (Product Part Identifier â€œCap Shellâ€). For the seal coating, Product Part Identifier Reference = â€œB1â€, because the seal coat is applied to the bead.",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "patternString" : "Product Part Identifier Reference"
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:PPiDref.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "RelsProf",
        "short" : "Product Part Release Profile",
        "definition" : "The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "patternString" : "Product Part Release Profile"
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsProf.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "RelsMech",
        "short" : "Product Part Release Mechanism",
        "definition" : "The method employed to realize the specified part release profile. [Source: SME Defined] \nExample: matrix or reservoir",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "patternString" : "Product Part Release Mechanism"
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:RelsMech.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "CoatPurpose",
        "short" : "Coating Product Part Purpose",
        "definition" : "The reason the coating or covering was added. [Source: SME Defined]\nExamples: rate-controlling, color, release type, protective, taste masking.",
        "min" : 0,
        "max" : "*",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "patternString" : "Coating Product Part Purpose"
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:CoatPurpose.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose"
        }
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "Color",
        "short" : "Product Part Color Description",
        "definition" : "The hue or the tint of the drug product part. [Source: SME Defined]\nExamples: yellow, pink, blue, pale yellow.",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "patternString" : "Product Part Color Description"
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:Color.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo",
        "path" : "ManufacturedItemDefinition.component.property",
        "sliceName" : "AddInfo",
        "short" : "Product Part Additional Information",
        "definition" : "A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.\nImplementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes.",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.type.text",
        "path" : "ManufacturedItemDefinition.component.property.type.text",
        "patternString" : "Product Part Additional Information"
      },
      {
        "id" : "ManufacturedItemDefinition.component.property:AddInfo.value[x]",
        "path" : "ManufacturedItemDefinition.component.property.value[x]",
        "min" : 1,
        "type" : [
          {
            "code" : "markdown"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "ManufacturedItemDefinition.component.component",
        "path" : "ManufacturedItemDefinition.component.component",
        "mustSupport" : true
      }
    ]
  }
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.