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

: PlanDefinition - Drug - example, stability study protocol - XML Representation

Active as of 2024-05-08

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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>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="plandefinition-drug-pq-ex5-stability-study-protocol"> </a><a name="hcplandefinition-drug-pq-ex5-stability-study-protocol"> </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-ex5-stability-study-protocol&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PlanDefinition-drug-pq.html">PlanDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol</code></p><p><b>identifier</b>: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.5</p><p><b>version</b>: 1.0.0</p><p><b>title</b>: Stability Monitoring Program</p><p><b>type</b>: Stability Study Protocol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-plan-type.html">Pharmaceutical Plan Type Codes</a>#1244588)</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 Stability Study</p><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</p><blockquote><p><b>action</b></p><p><b>title</b>: Long-Term</p><p><b>description</b>: 25°C/60% RH</p><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></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="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 Stability Study"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
    <text value="World"/>
  </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>