Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

: Process 1.0

Active as of 2026-05-10

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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>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
  <table class="narrative-table">
    <tbody>
<tr>


<th colspan="2" scope="row" class="row-header">Metadata</th>


</tr>

<tr>


<th scope="row" class="row-header">Title</th>



<td class="content-container">Process 1.0</td>


</tr>



<tr>


<th scope="row" class="row-header">Version</th>



<td class="content-container">1.0.0</td>


</tr>







  
<tr>


<th scope="row" class="row-header">Identifier</th>



<td class="content-container">urn:oid:2.16.840.1.113883.4.642.40.41.34.2</td>


</tr>








<tr>


<th scope="row" class="row-header">Subject Type</th>



<td class="content-container"><a href="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>


</tr>



<tr>


<th scope="row" class="row-header">Jurisdiction</th>



<td class="content-container">
    World


</td>


</tr>








<tr>


<th scope="row" class="row-header">Steward (Publisher)</th>



<td class="content-container">HL7 International / Biomedical Research and Regulation</td>


</tr>



<tr>


<th scope="row" class="row-header">Steward Contact</th>



<td class="content-container">HL7 International / Biomedical Research and Regulation</td>


</tr>







<tr>


<th scope="row" class="row-header">Description</th>



<td class="content-container"><div><p>Narrative description of manufacturing process (5)</p>
</div></td>


</tr>






<tr>


<th scope="row" class="row-header">Type</th>



<td class="content-container">
    Workflow Definition


    Manufacturing Process


</td>


</tr>






<tr>
  <th colspan="2" scope="row" class="row-header">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>
</tr>

    </tbody>
  </table>
</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="2026-05-10T20:32:51+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>
  </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>