Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
{
"resourceType" : "PackagedProductDefinition",
"id" : "packagedproductdefinition-drug-pq-ex1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PackagedProductDefinition</b><a name=\"packagedproductdefinition-drug-pq-ex1\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PackagedProductDefinition "packagedproductdefinition-drug-pq-ex1" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PackagedProductDefinition-drug-pq.html\">PackagedProductDefinition - Drug PQ</a></p></div><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1</a></p><p><b>description</b>: 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’. </p><blockquote><p><b>packaging</b></p><p><b>type</b>: Box <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-packaging-type.html\">Packaging Type</a>#100000073498)</span></p><p><b>material</b>: Cardboard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-package-material.html\">Package Material</a>#200000003529)</span></p><h3>ShelfLifeStorages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Period[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2 year<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code a = 'a')</span></td></tr></table><p><b>manufacturer</b>: <a href=\"Organization-organization-drug-pq-ex1.html\">Organization/organization-drug-pq-ex1</a> "AAA Molybdenum Products, Inc."</p><blockquote><p><b>property</b></p><p><b>type</b>: Functional <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-packageProperty-local-pq.html\">CodeSystem - Package Property</a>#Functional)</span></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Quality Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-packageProperty-local-pq.html\">CodeSystem - Package Property</a>#Quality Standard)</span></p><p><b>value</b>: USP <661> Plastic Packaging Systems and Their Materials of Construction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-grade-local-pq.html\">CodeSystem - Grade</a>#USP)</span></p></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: Tape <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (closureTypes#1d2344)</span></p><p><b>componentPart</b>: true</p><p><b>material</b>: Plastic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (material#200000003208)</span></p><p><b>manufacturer</b>: <a href=\"Organization-organization-drug-pq-ex1.html\">Organization/organization-drug-pq-ex1</a> "AAA Molybdenum Products, Inc."</p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: Bottle <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-packaging-type.html\">Packaging Type</a>#100000073497)</span></p><p><b>material</b>: Glass <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-package-material.html\">Package Material</a>#200000003203)</span></p><p><b>manufacturer</b>: <a href=\"Organization-organization-drug-pq-ex1.html\">Organization/organization-drug-pq-ex1</a> "AAA Molybdenum Products, Inc."</p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>containedItem</b></p></blockquote><blockquote><p><b>packaging</b></p></blockquote></blockquote></blockquote></div>"
},
"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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Functional",
"display" : "Functional"
}
]
},
"valueBoolean" : false
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Quality Standard",
"display" : "Quality Standard"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq",
"code" : "USP",
"display" : "USP <661> Plastic Packaging Systems and Their Materials of Construction"
}
]
}
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "http://example.org/fhir/code/closureTypes",
"code" : "1d2344",
"display" : "Tape"
}
]
},
"componentPart" : true,
"material" : [
{
"coding" : [
{
"system" : "http://example.org/fhir/code/material",
"code" : "200000003208",
"display" : "Plastic"
}
]
}
],
"manufacturer" : [
{
🔗 "reference" : "Organization/organization-drug-pq-ex1"
}
],
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Quality Specification",
"display" : "Quality Specification"
}
]
},
"valueCodeableConcept" : {
"text" : "Quality Specification for closure is described"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Quality Standard",
"display" : "Quality Standard"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq",
"code" : "BP",
"display" : "Closure Quality Standard"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Narrative",
"display" : "Narrative"
}
]
},
"valueCodeableConcept" : {
"text" : "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://example.org/fhir/code/closureProperties",
"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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Quality Specification",
"display" : "Quality Specification"
}
]
},
"valueCodeableConcept" : {
"text" : "Quality Specification is described"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Quality Standard",
"display" : "Quality Standard"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq",
"code" : "USP",
"display" : "USP <661> Plastic Packaging Systems and Their Materials of Construction"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Narrative",
"display" : "Narrative"
}
]
},
"valueCodeableConcept" : {
"text" : "Suitability, protection, safety: conformance to criteria, performance, compabilitity"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"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://example.org/fhir/code/closureTypes",
"code" : "112344",
"display" : "Child Proof Cap"
}
]
},
"componentPart" : true,
"material" : [
{
"coding" : [
{
"system" : "http://example.org/fhir/code/material",
"code" : "112344ss",
"display" : "PVC"
}
]
}
],
"manufacturer" : [
{
🔗 "reference" : "Organization/organization-drug-pq-ex1"
}
],
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Quality Specification",
"display" : "Quality Specification"
}
]
},
"valueCodeableConcept" : {
"text" : "Quality Specification for closure is described"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Quality Standard",
"display" : "Quality Standard"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq",
"code" : "BP",
"display" : "Closure Quality Standard"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq",
"code" : "Narrative",
"display" : "Narrative"
}
]
},
"valueCodeableConcept" : {
"text" : "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://example.org/fhir/code/closureProperties",
"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."
}
}
]
}
]
}
]
}
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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QA Report
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