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

## : PlanDefinition - Drug - example, validation protocol - XML Representation

Active as of 2024-05-08

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    <PlanDefinition xmlns="http://hl7.org/fhir">
      <id value="plandefinition-drug-pq-ex1-validation-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-ex1-validation-protocol"> </a><a name="hcplandefinition-drug-pq-ex1-validation-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-ex1-validation-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-ex1-validation-protocol</code></p><p><b>identifier</b>: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.1</p><p><b>version</b>: 1.0.0</p><p><b>title</b>: DP PROCESS VALIDATION</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>#process-validation &quot;Process Validation&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>: 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>: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...</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>: Formulation Buffer Preparation Process Parameter Step</p><p><b>code</b>: Formulation Buffer Preparation Process Parameter Step <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#FormulationBufferPreparationProcessParameterStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Formulation Buffer Preparation Process Parameter Step</p><p><b>code</b>: FormulationBufferPreparationProcessParameterStep <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Formulation Buffer Preparation Performance Indicator Results</p><p><b>code</b>: Formulation Buffer Preparation Performance Indicator Results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#FormulationBufferPreparationPerformanceIndicatorStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Thawing and Formulation Process Parameter Results</p><p><b>code</b>: Thawing and Formulation Process Parameter Resultss <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#ThawingandFormulationProcessParameterResultsStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Thawing and Formulation Performance Indicator Results</p><p><b>code</b>: Thawing and Formulation Performance Indicator Results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#ThawingandFormulationPerformanceIndicatorResultsStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Bioburden Reduction Filtration Process Parameter Results</p><p><b>code</b>: Bioburden Reduction Filtration Process Parameter Results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#BioburdenReductionFiltrationProcessParameterResultsStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434">http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Bioburden Reduction Filtration Performance Indicator Results</p><p><b>code</b>: Bioburden Reduction Filtration Performance Indicator Results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#BioburdenReductionFiltrationPerformanceIndicatorResultsStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434">http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Media Challenge Hold Times</p><p><b>code</b>: Media Challenge Hold Times <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#MediaChallengeHoldTimesStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434">http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Media Challenge Results</p><p><b>code</b>: Media Challenge Results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#MediaChallengeResultsStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filtered Formulated Drug Product Performance Indicator Results</p><p><b>code</b>: Filtered Formulated Drug Product Performance Indicator Results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424">http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424">http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424">http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Fill Weight Summary</p><p><b>code</b>: Fill Weight Summary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#FillWeightSummaryStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filling Homogeneity Quality Attributes</p><p><b>code</b>: Filling Homogeneity Quality Attributes <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#FillingHomogeneityQualityAttributesStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Conclusion <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424">http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filling Results Summary</p><p><b>code</b>: Filling Results Summary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#FillingResultsSummaryStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524">http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524">http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Statistical Evaluation of Homogeneity Data</p><p><b>code</b>: Statistical Evaluation of Homogeneity Data <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#StatisticalEvaluationOfHomogeneityDataStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534">http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524">http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Consistency of the Lyophilization Process</p><p><b>code</b>: Consistency of the Lyophilization Process <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#ConsistencyoftheLyophilizationProcessStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72">http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72</a></td></tr><tr><td style="display: none">*</td><td>Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="Bundle-bundle-product-process-validation-pq-ex3-prod-bio.html">Lyophilization</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Lyophilization Homogeneity</p><p><b>code</b>: Lyophilization Homogeneity Results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#LyophilizationHomogeneityStep)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424">http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424">http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424</a></td></tr></table></blockquote></div>
      </text>
      <url
           value="http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol"/>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:oid:2.16.840.1.113883.4.642.40.41.34.1"/>
      </identifier>
      <version value="1.0.0"/>
      <title value="DP PROCESS VALIDATION"/>
      <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="process-validation"/>
          <display value="Process Validation"/>
        </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="Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies..."/>
      <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="Formulation Buffer Preparation Process Parameter Step"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="FormulationBufferPreparationProcessParameterStep"/>
            <display
                     value="Formulation Buffer Preparation Process Parameter Step"/>
          </coding>
          <text value="Formulation Buffer Preparation Process Parameter Step"/>
        </code>
        <action>
          <title value="Formulation Buffer Preparation Process Parameter Step"/>
          <code>
            <text value="FormulationBufferPreparationProcessParameterStep"/>
          </code>
          <action>
            <code>
              <text value="Conclusion"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
          </action>
        </action>
      </action>
      <action>
        <title
               value="Formulation Buffer Preparation Performance Indicator Results"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="FormulationBufferPreparationPerformanceIndicatorStep"/>
            <display
                     value="Formulation Buffer Preparation Performance Indicator Results"/>
          </coding>
        </code>
        <action>
          <title value="???"/>
          <code>
            <text value="???"/>
          </code>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424"/>
          </action>
        </action>
      </action>
      <action>
        <title value="Thawing and Formulation Process Parameter Results"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="ThawingandFormulationProcessParameterResultsStep"/>
            <display value="Thawing and Formulation Process Parameter Resultss"/>
          </coding>
        </code>
        <action>
          <title value="???"/>
          <code>
            <text value="???"/>
          </code>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73"/>
          </action>
        </action>
      </action>
      <action>
        <title value="Thawing and Formulation Performance Indicator Results"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="ThawingandFormulationPerformanceIndicatorResultsStep"/>
            <display
                     value="Thawing and Formulation Performance Indicator Results"/>
          </coding>
        </code>
        <action>
          <title value="???"/>
          <code>
            <text value="???"/>
          </code>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424"/>
          </action>
          <action>
            <code>
              <text value="Test"/>
            </code>
            <definitionCanonical
                                 value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434"/>
          </action>
        </action>
      </action>
      <action>
        <title value="Bioburden Reduction Filtration Process Parameter Results"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code
                  value="BioburdenReductionFiltrationProcessParameterResultsStep"/>
            <display
                     value="Bioburden Reduction Filtration Process Parameter Results"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434"/>
        </action>
      </action>
      <action>
        <title
               value="Bioburden Reduction Filtration Performance Indicator Results"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code
                  value="BioburdenReductionFiltrationPerformanceIndicatorResultsStep"/>
            <display
                     value="Bioburden Reduction Filtration Performance Indicator Results"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434"/>
        </action>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434"/>
        </action>
      </action>
      <action>
        <title value="Media Challenge Hold Times"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="MediaChallengeHoldTimesStep"/>
            <display value="Media Challenge Hold Times"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434"/>
        </action>
      </action>
      <action>
        <title value="Media Challenge Results"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="MediaChallengeResultsStep"/>
            <display value="Media Challenge Results"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524"/>
        </action>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524"/>
        </action>
      </action>
      <action>
        <title
               value="Filtered Formulated Drug Product Performance Indicator Results"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code
                  value="FilteredFormulatedDrugProductPerformanceIndicatorResultsStep"/>
            <display
                     value="Filtered Formulated Drug Product Performance Indicator Results"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"/>
        </action>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424"/>
        </action>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"/>
        </action>
      </action>
      <action>
        <title value="Fill Weight Summary"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="FillWeightSummaryStep"/>
            <display value="Fill Weight Summary"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524"/>
        </action>
      </action>
      <action>
        <title value="Filling Homogeneity Quality Attributes"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="FillingHomogeneityQualityAttributesStep"/>
            <display value="Filling Homogeneity Quality Attributes"/>
          </coding>
          <text value="Filling Homogeneity Quality Attributes"/>
        </code>
        <action>
          <code>
            <text value="Conclusion"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424"/>
        </action>
      </action>
      <action>
        <title value="Filling Results Summary"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="FillingResultsSummaryStep"/>
            <display value="Filling Results Summary"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524"/>
        </action>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"/>
        </action>
      </action>
      <action>
        <title value="Statistical Evaluation of Homogeneity Data"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="StatisticalEvaluationOfHomogeneityDataStep"/>
            <display value="Statistical Evaluation of Homogeneity Data"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534"/>
        </action>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"/>
        </action>
      </action>
      <action>
        <title value="Consistency of the Lyophilization Process"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="ConsistencyoftheLyophilizationProcessStep"/>
            <display value="Consistency of the Lyophilization Process"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72"/>
        </action>
        <action>
          <code>
            <text value="Definition"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd"/>
        </action>
      </action>
      <action>
        <title value="Lyophilization Homogeneity"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
            <code value="LyophilizationHomogeneityStep"/>
            <display value="Lyophilization Homogeneity Results"/>
          </coding>
        </code>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424"/>
        </action>
        <action>
          <code>
            <text value="Test"/>
          </code>
          <definitionCanonical
                               value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424"/>
        </action>
      </action>
    </PlanDefinition>