Package | hl7.fhir.us.pq-cmc-fda |
Type | StructureDefinition |
Id | Id |
FHIR Version | R5 |
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 | 1.1.6 |
Status | active |
Date | 2024-09-17T03:56:09+00:00 |
Name | FinishedProduct |
Title | Manufactured Drug Product |
Experimental | False |
Realm | us |
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 |
StructureDefinition | |
cmc-ectd-document-32p10 | CMC eCTD 32P10 Document |
ectd-composition-32p10 | eCTD Product Description and Composition |
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 |
meta | ||||
profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
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 | ||||
coding | 0..* | Coding | Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required) | |
Slices for property | S | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type |
property:OvrRelsProf | S | 1..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Product Overall Release Profile Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: OvrRelsProf | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Overall Release Profile | |
Slices for value[x] | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
value[x]:valueCodeableConcept | S | 1..1 | CodeableConcept | A value for the characteristic |
coding | 0..* | Coding | Code defined by a terminology system Binding: Release Profile Terminology (required) | |
property:OvrRelsMech | S | 0..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Product Overall Release Mechanism Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: OvrRelsMech | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Overall Release Mechanism | |
Slices for value[x] | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
value[x]:valueCodeableConcept | S | 1..1 | CodeableConcept | A value for the characteristic |
coding | 0..* | Coding | Code defined by a terminology system Binding: Release Mechanism Terminology (required) | |
property:CoatInd | S | 0..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Product Coating Indicator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CoatInd | |
display | 1..1 | string | Representation defined by the system Fixed Value: Coating Indicator | |
Slices for value[x] | 1..1 | boolean | A value for the characteristic Slice: Unordered, Open by type:$this | |
value[x]:valueBoolean | S | 1..1 | boolean | A value for the characteristic |
property:LayCnt | S | 0..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Product Tablet Layer Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: TabLayCnt | |
display | 1..1 | string | Representation defined by the system Fixed Value: Tablet Layer Count | |
value[x] | S | 1..1 | Quantity | A value for the characteristic |
unit | 0..1 | string | Unit representation Required Pattern: 1* | |
system | 0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 0..1 | code | Coded form of the unit Required Pattern: C66832 | |
property:BeaTypCnt | S | 0..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Tablet Bead Type Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: BeaTypCnt | |
display | 1..1 | string | Representation defined by the system Fixed Value: Tablet Bead Type Count | |
value[x] | S | 1..1 | Quantity | A value for the characteristic |
unit | 0..1 | string | Unit representation Required Pattern: 1* | |
system | 0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 0..1 | code | Coded form of the unit Required Pattern: C66832 | |
property:CapClass | S | 0..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Capsule Shell Part Classification Category Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CapClass | |
display | 1..1 | string | Representation defined by the system Fixed Value: Capsule Classification Category | |
Slices for value[x] | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
value[x]:valueCodeableConcept | S | 1..1 | CodeableConcept | A value for the characteristic |
coding | 0..* | Coding | Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required) | |
property:CapConCnt | S | 0..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Product Capsule Constituent Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CapConCnt | |
display | 1..1 | string | Representation defined by the system Fixed Value: Capsule Constituent Count | |
value[x] | S | 1..1 | Quantity | A value for the characteristic |
unit | 0..1 | string | Unit representation Required Pattern: 1* | |
system | 0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 0..1 | code | Coded form of the unit Required Pattern: C66832 | |
property:Schematic | S | 1..* | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Product Schematic Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: Schematic | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Schematic | |
Slices for value[x] | 1..1 | Attachment | A value for the characteristic Slice: Unordered, Open by type:$this | |
value[x]:valueAttachment | S | 1..1 | Attachment | A value for the characteristic |
property:WgtTyp | S | 1..1 | BackboneElement | General characteristics of this item |
type | S | 1..1 | CodeableConcept | Product Weight Type Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: WgtTyp | |
display | 1..1 | string | Representation defined by the system Fixed Value: Product Weight Type | |
Slices for value[x] | 1..1 |