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
| Active as of 2024-05-08 |
<PlanDefinition xmlns="http://hl7.org/fhir">
<id value="plandefinition-drug-pq-ex2-manufacturing-plan"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
<tag>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ObservationValue"/>
<code value="SUBSETTED"/>
</tag>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="plandefinition-drug-pq-ex2-manufacturing-plan"> </a><a name="hcplandefinition-drug-pq-ex2-manufacturing-plan"> </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 PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PlanDefinition-drug-pq.html">PlanDefinition - Drug PQ</a></p><p style="margin-bottom: 0px">Tag: <span title="{http://terminology.hl7.org/CodeSystem/v3-ObservationValue http://terminology.hl7.org/CodeSystem/v3-ObservationValue}">http://terminology.hl7.org/CodeSystem/v3-ObservationValue</span></p></div><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan</code></p><p><b>identifier</b>: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.2</p><p><b>version</b>: 1.0.0</p><p><b>title</b>: Process 1.0</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-pharmaceutical-plan-type.html">Pharmaceutical Plan Type Codes</a>#manufacturing-process "Manufacturing Process")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html">MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1</a></p><p><b>date</b>: 2024-05-08 12:53:57+0000</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International - Biomedical Research and Regulation: <a href="http://www.hl7.org/Special/committees/rcrim">http://www.hl7.org/Special/committees/rcrim</a></p><p><b>description</b>: Narrative description of manufacturing process (5)</p><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-pH</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-test-category.html">Pharmaceutical Test Category Codes</a>#C123456)</span></p><p><b>description</b>: Controls - pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-pq-example.html">Goal Priority - example</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>pH must be in range 6.9 to 7.1 <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>#pH "pH")</span></td><td>6.9-7.1 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-water-content</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-test-category.html">Pharmaceutical Test Category Codes</a>#C123456)</span></p><p><b>description</b>: Controls - Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-pq-example.html">Goal Priority - example</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Under 2% <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>#WaterContent "Water content")</span></td><td>?-2</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-particle-size</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-test-category.html">Pharmaceutical Test Category Codes</a>#C123456)</span></p><p><b>description</b>: Controls - Particle Size <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-pq-example.html">Goal Priority - example</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Under 200 microns <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>#particle-size "Particle Size")</span></td><td>?-200</td></tr></table></blockquote></div>
</text>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq">
<valueMarkdown value="This can be text about the history"/>
</extension>
<url
value="http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.41.34.2"/>
</identifier>
<version value="1.0.0"/>
<title value="Process 1.0"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</coding>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
<code value="manufacturing-process"/>
<display value="Manufacturing Process"/>
</coding>
</type>
<status value="active"/>
<subjectReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</subjectReference>
<date value="2024-05-08T12:53:57+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International - Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
</contact>
<description value="Narrative description of manufacturing process (5)"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
<text value="World"/>
</jurisdiction>
<goal id="goal-control-pH">
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"/>
<code value="C123456"/>
<display value="Physical Property"/>
</coding>
</category>
<description>
<text value="Controls - pH"/>
</description>
<priority>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example"/>
<code value="critical"/>
<display value="Critical"/>
</coding>
</priority>
<target>
<measure>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="pH"/>
<display value="pH"/>
</coding>
<text value="pH must be in range 6.9 to 7.1"/>
</measure>
<detailRange>
<low>
<value value="6.9"/>
<unit value="pH"/>
</low>
<high>
<value value="7.1"/>
<unit value="pH"/>
</high>
</detailRange>
</target>
</goal>
<goal id="goal-control-water-content">
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"/>
<code value="C123456"/>
<display value="Physical Property"/>
</coding>
</category>
<description>
<text value="Controls - Water Content"/>
</description>
<priority>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example"/>
<code value="critical"/>
<display value="Critical"/>
</coding>
</priority>
<target>
<measure>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="WaterContent"/>
<display value="Water content"/>
</coding>
<text value="Under 2%"/>
</measure>
<detailRange>
<high>
<value value="2"/>
<unit value="%"/>
</high>
</detailRange>
</target>
</goal>
<goal id="goal-control-particle-size">
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"/>
<code value="C123456"/>
<display value="Physical Property"/>
</coding>
</category>
<description>
<text value="Controls - Particle Size"/>
</description>
<priority>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example"/>
<code value="critical"/>
<display value="Critical"/>
</coding>
</priority>
<target>
<measure>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="particle-size"/>
<display value="Particle Size"/>
</coding>
<text value="Under 200 microns"/>
</measure>
<detailRange>
<high>
<value value="200"/>
<unit value="microns"/>
</high>
</detailRange>
</target>
</goal>
</PlanDefinition>
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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