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
<PackagedProductDefinition xmlns="http://hl7.org/fhir">
<id value="packagedproductdefinition-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</packageFor>
<description
value="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 value="http://hl7.org/fhir/packaging-type"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<material>
<coding>
<system value="http://hl7.org/fhir/package-material"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<shelfLifeStorage>
<periodDuration>
<value value="2"/>
<unit value="year"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
</periodDuration>
</shelfLifeStorage>
<manufacturer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</manufacturer>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Functional"/>
<display value="Functional"/>
</coding>
</type>
<valueBoolean value="false"/>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Quality Standard"/>
<display value="Quality Standard"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-grade"/>
<code value="USP"/>
<display
value="USP <661> Plastic Packaging Systems and Their Materials of Construction"/>
</coding>
</valueCodeableConcept>
</property>
<packaging>
<type>
<coding>
<!-- <system value="http://example.org/fhir/code/closureTypes"/> -->
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="1d2344"/>
<display value="Tape"/>
</coding>
</type>
<componentPart value="true"/>
<material>
<coding>
<!-- <system value="http://example.org/fhir/code/material"/> -->
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="200000003208"/>
<display value="Plastic"/>
</coding>
</material>
<manufacturer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</manufacturer>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Quality Specification"/>
<display value="Quality Specification"/>
</coding>
</type>
<valueCodeableConcept>
<text value="Quality Specification for closure is described"/>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Quality Standard"/>
<display value="Quality Standard"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-grade"/>
<code value="BP"/>
<display value="Closure Quality Standard"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Narrative"/>
<display value="Narrative"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"/>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<!-- <system value="http://example.org/fhir/code/closureProperties"/> -->
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="1123ss"/>
<display value="Integrity Test"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."/>
</valueCodeableConcept>
</property>
</packaging>
<packaging>
<type>
<coding>
<system value="http://hl7.org/fhir/packaging-type"/>
<code value="100000073497"/>
<display value="Bottle"/>
</coding>
</type>
<material>
<coding>
<system value="http://hl7.org/fhir/package-material"/>
<code value="200000003203"/>
<display value="Glass"/>
</coding>
</material>
<manufacturer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</manufacturer>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Quality Specification"/>
<display value="Quality Specification"/>
</coding>
</type>
<valueCodeableConcept>
<text value="Quality Specification is described"/>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Quality Standard"/>
<display value="Quality Standard"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-grade"/>
<code value="USP"/>
<display
value="USP <661> Plastic Packaging Systems and Their Materials of Construction"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Narrative"/>
<display value="Narrative"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Suitability, protection, safety: conformance to criteria, performance, compabilitity"/>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Container Size"/>
<display value="Container Size"/>
</coding>
</type>
<valueQuantity>
<value value="250"/>
<unit value="ml"/>
</valueQuantity>
</property>
<containedItem>
<item>
<extension
url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
<valueCode value="unsupported"/>
</extension>
</item>
<amount>
<value value="100"/>
<unit value="mg"/>
</amount>
</containedItem>
<packaging>
<type>
<coding>
<!-- <system value="http://example.org/fhir/code/closureTypes"/> -->
<system
value="http://terminology.hl7.org/CodeSystem/container-closure-type"/>
<!-- <code value="112344"/> -->
<code value="Child Proof Cap"/>
<display value="Child Proof Cap"/>
</coding>
</type>
<componentPart value="true"/>
<material>
<coding>
<!-- <system value="http://example.org/fhir/code/material"/> -->
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="112344ss"/>
<display value="PVC"/>
</coding>
</material>
<manufacturer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</manufacturer>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Quality Specification"/>
<display value="Quality Specification"/>
</coding>
</type>
<valueCodeableConcept>
<text value="Quality Specification for closure is described"/>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Quality Standard"/>
<display value="Quality Standard"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-grade"/>
<code value="BP"/>
<display value="Closure Quality Standard"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="Narrative"/>
<display value="Narrative"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"/>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<!-- <system value="http://example.org/fhir/code/closureProperties"/> -->
<system
value="http://terminology.hl7.org/CodeSystem/package-property"/>
<code value="1123ss"/>
<display value="Integrity Test"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."/>
</valueCodeableConcept>
</property>
</packaging>
</packaging>
</packaging>
</PackagedProductDefinition>
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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