Pharmaceutical Quality (Industry)
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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

: Stability Monitoring Program

Active as of 2026-05-10

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<PlanDefinition xmlns="http://hl7.org/fhir">
  <id value="plandefinition-drug-pq-ex5-stability-study-protocol"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
  </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">Stability Monitoring Program</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:2.16.840.1.113883.4.642.40.41.34.5</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 Stability Study</p>
</div></td>


</tr>






<tr>


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



<td class="content-container">
    Stability Study Protocol


</td>


</tr>




<tr>


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


</tr>




<tr>


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



<td class="content-container">Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</td>


</tr>
























  
    
    
      
      
<tr>


<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg)</th>


</tr>




<tr>


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



<td class="content-container">Long-Term</td>


</tr>


<tr>


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



<td class="content-container"><div><p>25°C/60% RH</p>
</div></td>


</tr>























  
    
    
      
      
<tr>


<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Long-Term)</th>


</tr>




<tr>


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



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


</tr>













<tr>


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



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


</tr>












  
    
    
      
      
<tr>


<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Initial)</th>


</tr>




<tr>


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



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


</tr>




















<tr>


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



<td class="content-container"><code>http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90</code></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>
  <url
       value="http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.41.34.5"/>
  </identifier>
  <version value="1.0.0"/>
  <title value="Stability Monitoring Program"/>
  <type>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
      <code value="1244588"/>
      <display value="Stability Study Protocol"/>
    </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 Stability Study"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <action>
    <title
           value="Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg"/>
    <action>
      <title value="Long-Term"/>
      <description value="25°C/60% RH"/>
      <action>
        <title value="Initial"/>
        <timingTiming>
          <repeat>
            <boundsRange>
              <low>
                <value value="0"/>
                <unit value="months"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="mo"/>
              </low>
              <high>
                <value value="0"/>
                <unit value="months"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="mo"/>
              </high>
            </boundsRange>
            <frequency value="1"/>
          </repeat>
        </timingTiming>
        <action>
          <title value="XYZ"/>
          <definitionCanonical
                               value="http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
        </action>
      </action>
    </action>
  </action>
</PlanDefinition>