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

: ValueSet - Manufacturing Step - XML Representation

Active as of 2023-12-18

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="vs-manufacturingStep-local-pq"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><ul><li>Include these codes as defined in <a href="CodeSystem-cs-manufacturingStep-local-pq.html"><code>http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-Mixingofingredients">Mixing of ingredients</a></td><td>Mixing of ingredients</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-drying">drying</a></td><td>Drying</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-particleSizeReduction">particleSizeReduction</a></td><td>Particle Size Reduction</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-overallprocess">overall process</a></td><td>Overall Process</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-compounding">compounding</a></td><td>Compounding Step</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-filling">filling</a></td><td>Filling Step</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-lyophilization">lyophilization</a></td><td>Lyophilization Step</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-release">release</a></td><td>Release Step</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-Step1In-ProcessControlData">Step1In-ProcessControlData</a></td><td>Step 1 In-Process Control Data</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-Step1DSReleaseTestingResults">Step1DSReleaseTestingResults</a></td><td>Step 1 DS Release Testing Results</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-FormulationBufferPreparationProcessParameterStep">FormulationBufferPreparationProcessParameterStep</a></td><td>Formulation Buffer Preparation Process Parameter Step</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-FormulationBufferPreparationPerformanceIndicatorStep">FormulationBufferPreparationPerformanceIndicatorStep</a></td><td>Formulation Buffer Preparation Performance Indicator Results</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-ThawingandFormulationProcessParameterResultsStep">ThawingandFormulationProcessParameterResultsStep</a></td><td>Thawing and Formulation Process Parameter Resultss</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-ThawingandFormulationPerformanceIndicatorResultsStep">ThawingandFormulationPerformanceIndicatorResultsStep</a></td><td>Thawing and Formulation Performance Indicator Results</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-BioburdenReductionFiltrationProcessParameterResultsStep">BioburdenReductionFiltrationProcessParameterResultsStep</a></td><td>Bioburden Reduction Filtration Process Parameter Results</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-BioburdenReductionFiltrationPerformanceIndicatorResultsStep">BioburdenReductionFiltrationPerformanceIndicatorResultsStep</a></td><td>Bioburden Reduction Filtration Performance Indicator Results</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-MediaChallengeHoldTimesStep">MediaChallengeHoldTimesStep</a></td><td>Media Challenge Hold Times</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-MediaChallengeResultsStep">MediaChallengeResultsStep</a></td><td>Media Challenge Results</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-FilteredFormulatedDrugProductPerformanceIndicatorResultsStep">FilteredFormulatedDrugProductPerformanceIndicatorResultsStep</a></td><td>Filtered Formulated Drug Product Performance Indicator Results</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-FillWeightSummaryStep">FillWeightSummaryStep</a></td><td>Fill Weight Summary</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-FillingHomogeneityQualityAttributesStep">FillingHomogeneityQualityAttributesStep</a></td><td>Filling Homogeneity Quality Attributes</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-FillingResultsSummaryStep">FillingResultsSummaryStep</a></td><td>Filling Results Summary</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-StatisticalEvaluationOfHomogeneityDataStep">StatisticalEvaluationOfHomogeneityDataStep</a></td><td>Statistical Evaluation of Homogeneity Data</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-ConsistencyoftheLyophilizationProcessStep">ConsistencyoftheLyophilizationProcessStep</a></td><td>Consistency of the Lyophilization Process</td></tr><tr><td><a href="CodeSystem-cs-manufacturingStep-local-pq.html#cs-manufacturingStep-local-pq-LyophilizationHomogeneityStep">LyophilizationHomogeneityStep</a></td><td>Lyophilization Homogeneity Results</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingStep-local-pq"/>
  <version value="1.0.0-ballot"/>
  <name value="VsManufacturingStepPQ"/>
  <title value="ValueSet - Manufacturing Step"/>
  <status value="active"/>
  <experimental value="false"/>
  <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="This value set contains example codes for manufacturing step in PQ."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
    <text value="World"/>
  </jurisdiction>
  <compose>
    <include>
      <system
              value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
      <concept>
        <code value="Mixing of ingredients"/>
        <display value="Mixing of ingredients"/>
      </concept>
      <concept>
        <code value="drying"/>
        <display value="Drying"/>
      </concept>
      <concept>
        <code value="particleSizeReduction"/>
        <display value="Particle Size Reduction"/>
      </concept>
      <concept>
        <code value="overall process"/>
        <display value="Overall Process"/>
      </concept>
      <concept>
        <code value="compounding"/>
        <display value="Compounding Step"/>
      </concept>
      <concept>
        <code value="filling"/>
        <display value="Filling Step"/>
      </concept>
      <concept>
        <code value="lyophilization"/>
        <display value="Lyophilization Step"/>
      </concept>
      <concept>
        <code value="release"/>
        <display value="Release Step"/>
      </concept>
      <concept>
        <code value="Step1In-ProcessControlData"/>
        <display value="Step 1 In-Process Control Data"/>
      </concept>
      <concept>
        <code value="Step1DSReleaseTestingResults"/>
        <display value="Step 1 DS Release Testing Results"/>
      </concept>
      <concept>
        <code value="FormulationBufferPreparationProcessParameterStep"/>
        <display
                 value="Formulation Buffer Preparation Process Parameter Step"/>
      </concept>
      <concept>
        <code value="FormulationBufferPreparationPerformanceIndicatorStep"/>
        <display
                 value="Formulation Buffer Preparation Performance Indicator Results"/>
      </concept>
      <concept>
        <code value="ThawingandFormulationProcessParameterResultsStep"/>
        <display value="Thawing and Formulation Process Parameter Resultss"/>
      </concept>
      <concept>
        <code value="ThawingandFormulationPerformanceIndicatorResultsStep"/>
        <display
                 value="Thawing and Formulation Performance Indicator Results"/>
      </concept>
      <concept>
        <code
              value="BioburdenReductionFiltrationProcessParameterResultsStep"/>
        <display
                 value="Bioburden Reduction Filtration Process Parameter Results"/>
      </concept>
      <concept>
        <code
              value="BioburdenReductionFiltrationPerformanceIndicatorResultsStep"/>
        <display
                 value="Bioburden Reduction Filtration Performance Indicator Results"/>
      </concept>
      <concept>
        <code value="MediaChallengeHoldTimesStep"/>
        <display value="Media Challenge Hold Times"/>
      </concept>
      <concept>
        <code value="MediaChallengeResultsStep"/>
        <display value="Media Challenge Results"/>
      </concept>
      <concept>
        <code
              value="FilteredFormulatedDrugProductPerformanceIndicatorResultsStep"/>
        <display
                 value="Filtered Formulated Drug Product Performance Indicator Results"/>
      </concept>
      <concept>
        <code value="FillWeightSummaryStep"/>
        <display value="Fill Weight Summary"/>
      </concept>
      <concept>
        <code value="FillingHomogeneityQualityAttributesStep"/>
        <display value="Filling Homogeneity Quality Attributes"/>
      </concept>
      <concept>
        <code value="FillingResultsSummaryStep"/>
        <display value="Filling Results Summary"/>
      </concept>
      <concept>
        <code value="StatisticalEvaluationOfHomogeneityDataStep"/>
        <display value="Statistical Evaluation of Homogeneity Data"/>
      </concept>
      <concept>
        <code value="ConsistencyoftheLyophilizationProcessStep"/>
        <display value="Consistency of the Lyophilization Process"/>
      </concept>
      <concept>
        <code value="LyophilizationHomogeneityStep"/>
        <display value="Lyophilization Homogeneity Results"/>
      </concept>
    </include>
  </compose>
</ValueSet>