FHIR IG analytics| Package | hl7.fhir.uv.pharm-quality |
| Resource Type | PackagedProductDefinition |
| Id | PackagedProductDefinition-packagedproductdefinition-drug-pq-ex1.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: PackagedProductDefinition
Resource PackagedProductDefinition "packagedproductdefinition-drug-pq-ex1"
Profile: PackagedProductDefinition - Drug PQ
packageFor: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
description: The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap. Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’.
packaging
type: Box (Packaging Type#100000073498)
material: Cardboard (Package Material#200000003529)
ShelfLifeStorages
Period[x] 2 year (Details: UCUM code a = 'a') manufacturer: Organization/organization-drug-pq-ex1 "AAA Molybdenum Products, Inc."
property
type: Functional (Package Property Codes#Functional)
value: false
property
type: Quality Standard (Package Property Codes#Quality Standard)
value: USP <661> Plastic Packaging Systems and Their Materials of Construction (Package Grade Codes#USP)
packaging
type: Tape (Example Local Codes - Drug#1d2344)
componentPart: true
material: Plastic (Example Local Codes - Drug#200000003208)
manufacturer: Organization/organization-drug-pq-ex1 "AAA Molybdenum Products, Inc."
property
property
property
property
packaging
type: Bottle (Packaging Type#100000073497)
material: Glass (Package Material#200000003203)
manufacturer: Organization/organization-drug-pq-ex1 "AAA Molybdenum Products, Inc."
property
property
property
property
containedItem
packaging
{
"resourceType": "PackagedProductDefinition",
"id": "packagedproductdefinition-drug-pq-ex1",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"
]
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"packageFor": [
{
"reference": "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
}
],
"description": "The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap. Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’.",
"packaging": {
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/packaging-type",
"code": "100000073498",
"display": "Box"
}
]
},
"material": [
{
"coding": [
{
"system": "http://hl7.org/fhir/package-material",
"code": "200000003529",
"display": "Cardboard"
}
]
}
],
"shelfLifeStorage": [
{
"periodDuration": {
"value": 2,
"unit": "year",
"system": "http://unitsofmeasure.org",
"code": "a"
}
}
],
"manufacturer": [
{
"reference": "Organization/organization-drug-pq-ex1"
}
],
"property": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Functional",
"display": "Functional"
}
]
},
"valueBoolean": false
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Quality Standard",
"display": "Quality Standard"
}
]
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-grade",
"code": "USP",
"display": "USP <661> Plastic Packaging Systems and Their Materials of Construction"
}
]
}
}
],
"packaging": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
"code": "1d2344",
"display": "Tape"
}
]
},
"componentPart": true,
"material": [
{
"coding": [
{
"system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
"code": "200000003208",
"display": "Plastic"
}
]
}
],
"manufacturer": [
{
"reference": "Organization/organization-drug-pq-ex1"
}
],
"property": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Quality Specification",
"display": "Quality Specification"
}
]
},
"valueCodeableConcept": {
"text": "Quality Specification for closure is described"
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Quality Standard",
"display": "Quality Standard"
}
]
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-grade",
"code": "BP",
"display": "Closure Quality Standard"
}
]
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Narrative",
"display": "Narrative"
}
]
},
"valueCodeableConcept": {
"text": "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "1123ss",
"display": "Integrity Test"
}
]
},
"valueCodeableConcept": {
"text": "Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."
}
}
]
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/packaging-type",
"code": "100000073497",
"display": "Bottle"
}
]
},
"material": [
{
"coding": [
{
"system": "http://hl7.org/fhir/package-material",
"code": "200000003203",
"display": "Glass"
}
]
}
],
"manufacturer": [
{
"reference": "Organization/organization-drug-pq-ex1"
}
],
"property": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Quality Specification",
"display": "Quality Specification"
}
]
},
"valueCodeableConcept": {
"text": "Quality Specification is described"
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Quality Standard",
"display": "Quality Standard"
}
]
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-grade",
"code": "USP",
"display": "USP <661> Plastic Packaging Systems and Their Materials of Construction"
}
]
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Narrative",
"display": "Narrative"
}
]
},
"valueCodeableConcept": {
"text": "Suitability, protection, safety: conformance to criteria, performance, compabilitity"
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Container Size",
"display": "Container Size"
}
]
},
"valueQuantity": {
"value": 250,
"unit": "ml"
}
}
],
"containedItem": [
{
"item": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
"valueCode": "unsupported"
}
]
},
"amount": {
"value": 100,
"unit": "mg"
}
}
],
"packaging": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/container-closure-type",
"code": "Child Proof Cap",
"display": "Child Proof Cap"
}
]
},
"componentPart": true,
"material": [
{
"coding": [
{
"system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
"code": "112344ss",
"display": "PVC"
}
]
}
],
"manufacturer": [
{
"reference": "Organization/organization-drug-pq-ex1"
}
],
"property": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Quality Specification",
"display": "Quality Specification"
}
]
},
"valueCodeableConcept": {
"text": "Quality Specification for closure is described"
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Quality Standard",
"display": "Quality Standard"
}
]
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-grade",
"code": "BP",
"display": "Closure Quality Standard"
}
]
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "Narrative",
"display": "Narrative"
}
]
},
"valueCodeableConcept": {
"text": "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"
}
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/package-property",
"code": "1123ss",
"display": "Integrity Test"
}
]
},
"valueCodeableConcept": {
"text": "Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."
}
}
]
}
]
}
]
}
}