Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:PackagedProductDefinition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "packagedproductdefinition-drug-pq-ex1"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PackagedProductDefinition</b><a name=\"packagedproductdefinition-drug-pq-ex1\"> </a><a name=\"hcpackagedproductdefinition-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-package-property.html\">Package Property Codes</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-package-property.html\">Package Property Codes</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-package-grade.html\">Package Grade Codes</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\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#1d2344)</span></p><p><b>componentPart</b>: true</p><p><b>material</b>: Plastic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#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>"
] ; #
fhir:packageFor ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" ]
] ) ; #
fhir:description [ fhir:v "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’."] ; #
fhir:packaging [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/packaging-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073498" ] ;
fhir:display [ fhir:v "Box" ] ] ) ] ;
( fhir:material [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/package-material"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000003529" ] ;
fhir:display [ fhir:v "Cardboard" ] ] ) ] ) ;
( fhir:shelfLifeStorage [
fhir:period [
a fhir:Duration ;
fhir:value [ fhir:v "2"^^xsd:decimal ] ;
fhir:unit [ fhir:v "year" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "a" ] ] ] ) ;
( fhir:manufacturer [
fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ) ;
( fhir:property [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Functional" ] ;
fhir:display [ fhir:v "Functional" ] ] ) ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Quality Standard" ] ;
fhir:display [ fhir:v "Quality Standard" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ;
fhir:code [ fhir:v "USP" ] ;
fhir:display [ fhir:v "USP <661> Plastic Packaging Systems and Their Materials of Construction" ] ] ) ] ] ) ;
( fhir:packaging [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ; # <system value=\"http:\/\/example.org\/fhir\/code\/closureTypes\"\/>
fhir:code [ fhir:v "1d2344" ] ;
fhir:display [ fhir:v "Tape" ] ] ) ] ;
fhir:componentPart [ fhir:v "true"^^xsd:boolean ] ;
( fhir:material [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ; # <system value=\"http:\/\/example.org\/fhir\/code\/material\"\/>
fhir:code [ fhir:v "200000003208" ] ;
fhir:display [ fhir:v "Plastic" ] ] ) ] ) ;
( fhir:manufacturer [
fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ) ;
( fhir:property [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Quality Specification" ] ;
fhir:display [ fhir:v "Quality Specification" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Quality Specification for closure is described" ] ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Quality Standard" ] ;
fhir:display [ fhir:v "Quality Standard" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ;
fhir:code [ fhir:v "BP" ] ;
fhir:display [ fhir:v "Closure Quality Standard" ] ] ) ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Narrative" ] ;
fhir:display [ fhir:v "Narrative" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity" ] ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; # <system value=\"http:\/\/example.org\/fhir\/code\/closureProperties\"\/>
fhir:code [ fhir:v "1123ss" ] ;
fhir:display [ fhir:v "Integrity Test" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap." ] ] ] ) ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/packaging-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073497" ] ;
fhir:display [ fhir:v "Bottle" ] ] ) ] ;
( fhir:material [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/package-material"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000003203" ] ;
fhir:display [ fhir:v "Glass" ] ] ) ] ) ;
( fhir:manufacturer [
fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ) ;
( fhir:property [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Quality Specification" ] ;
fhir:display [ fhir:v "Quality Specification" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Quality Specification is described" ] ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Quality Standard" ] ;
fhir:display [ fhir:v "Quality Standard" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ;
fhir:code [ fhir:v "USP" ] ;
fhir:display [ fhir:v "USP <661> Plastic Packaging Systems and Their Materials of Construction" ] ] ) ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Narrative" ] ;
fhir:display [ fhir:v "Narrative" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Suitability, protection, safety: conformance to criteria, performance, compabilitity" ] ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Container Size" ] ;
fhir:display [ fhir:v "Container Size" ] ] ) ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "250"^^xsd:decimal ] ;
fhir:unit [ fhir:v "ml" ] ] ] ) ;
( fhir:containedItem [
fhir:item [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/data-absent-reason"^^xsd:anyURI ] ;
fhir:value [ fhir:v "unsupported" ] ] ) ] ;
fhir:amount [
fhir:value [ fhir:v "100"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ] ] ) ;
( fhir:packaging [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-closure-type"^^xsd:anyURI ] ; # <system value=\"http:\/\/example.org\/fhir\/code\/closureTypes\"\/>
fhir:code [ fhir:v "Child Proof Cap" ] ; # <code value=\"112344\"\/>
fhir:display [ fhir:v "Child Proof Cap" ] ] ) ] ;
fhir:componentPart [ fhir:v "true"^^xsd:boolean ] ;
( fhir:material [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ; # <system value=\"http:\/\/example.org\/fhir\/code\/material\"\/>
fhir:code [ fhir:v "112344ss" ] ;
fhir:display [ fhir:v "PVC" ] ] ) ] ) ;
( fhir:manufacturer [
fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ) ;
( fhir:property [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Quality Specification" ] ;
fhir:display [ fhir:v "Quality Specification" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Quality Specification for closure is described" ] ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Quality Standard" ] ;
fhir:display [ fhir:v "Quality Standard" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ;
fhir:code [ fhir:v "BP" ] ;
fhir:display [ fhir:v "Closure Quality Standard" ] ] ) ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Narrative" ] ;
fhir:display [ fhir:v "Narrative" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity" ] ] ] [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; # <system value=\"http:\/\/example.org\/fhir\/code\/closureProperties\"\/>
fhir:code [ fhir:v "1123ss" ] ;
fhir:display [ fhir:v "Integrity Test" ] ] ) ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "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 based on FHIR 5.0.0. Generated 2024-05-08
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