Pharmaceutical Quality (Industry)
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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

: PlanDefinition - Drug - example, manufacturing plan - XML Representation

Active as of 2023-12-18

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<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></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 &quot;plandefinition-drug-pq-ex2-manufacturing-plan&quot; </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>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan</code></p><p><b>version</b>: 1.0.0-ballot</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-cs-planType-local-pq.html">CodeSystem - Plan Type</a>#manufacturing-process &quot;Manufacturing Process&quot;)</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>: 2023-12-18 16:00:45+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-cs-testCategory-local-pq.html">CodeSystem - Test Category</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-local-pq.html">CodeSystem - Goal Priority</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.html">CodeSystem - Example Local Codes - Drug</a>#pH &quot;pH&quot;)</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-cs-testCategory-local-pq.html">CodeSystem - Test Category</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-local-pq.html">CodeSystem - Goal Priority</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.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent &quot;Water content&quot;)</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-cs-testCategory-local-pq.html">CodeSystem - Test Category</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-local-pq.html">CodeSystem - Goal Priority</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.html">CodeSystem - Example Local Codes - Drug</a>#particle-size &quot;Particle Size&quot;)</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>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan"/>
  <version value="1.0.0-ballot"/>
  <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq"/>
      <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="2023-12-18T16:00:45+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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
        <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-local-pq"/>
        <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"/>
          <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
        <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-local-pq"/>
        <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"/>
          <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
        <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-local-pq"/>
        <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"/>
          <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>