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

## : Manufacturing Step Codes - XML Representation

Active as of 2024-05-08

Raw xml | Download

    <CodeSystem xmlns="http://hl7.org/fhir">
      <id value="manufacturing-step"/>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p>This case-sensitive code system <code>http://terminology.hl7.org/CodeSystem/manufacturing-step</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">Mixing of ingredients<a name="manufacturing-step-Mixingofingredients"> </a></td><td>Mixing of ingredients</td></tr><tr><td style="white-space:nowrap">drying<a name="manufacturing-step-drying"> </a></td><td>Drying</td></tr><tr><td style="white-space:nowrap">particleSizeReduction<a name="manufacturing-step-particleSizeReduction"> </a></td><td>Particle Size Reduction</td></tr><tr><td style="white-space:nowrap">overall process<a name="manufacturing-step-overallprocess"> </a></td><td>Overall Process</td></tr><tr><td style="white-space:nowrap">compounding<a name="manufacturing-step-compounding"> </a></td><td>Compounding Step</td></tr><tr><td style="white-space:nowrap">filling<a name="manufacturing-step-filling"> </a></td><td>Filling Step</td></tr><tr><td style="white-space:nowrap">lyophilization<a name="manufacturing-step-lyophilization"> </a></td><td>Lyophilization Step</td></tr><tr><td style="white-space:nowrap">release<a name="manufacturing-step-release"> </a></td><td>Release Step</td></tr><tr><td style="white-space:nowrap">Step1In-ProcessControlData<a name="manufacturing-step-Step1In-ProcessControlData"> </a></td><td>Step 1 In-Process Control Data</td></tr><tr><td style="white-space:nowrap">Step1DSReleaseTestingResults<a name="manufacturing-step-Step1DSReleaseTestingResults"> </a></td><td>Step 1 DS Release Testing Results</td></tr><tr><td style="white-space:nowrap">FormulationBufferPreparationProcessParameterStep<a name="manufacturing-step-FormulationBufferPreparationProcessParameterStep"> </a></td><td>Formulation Buffer Preparation Process Parameter Step</td></tr><tr><td style="white-space:nowrap">FormulationBufferPreparationPerformanceIndicatorStep<a name="manufacturing-step-FormulationBufferPreparationPerformanceIndicatorStep"> </a></td><td>Formulation Buffer Preparation Performance Indicator Results</td></tr><tr><td style="white-space:nowrap">ThawingandFormulationProcessParameterResultsStep<a name="manufacturing-step-ThawingandFormulationProcessParameterResultsStep"> </a></td><td>Thawing and Formulation Process Parameter Resultss</td></tr><tr><td style="white-space:nowrap">ThawingandFormulationPerformanceIndicatorResultsStep<a name="manufacturing-step-ThawingandFormulationPerformanceIndicatorResultsStep"> </a></td><td>Thawing and Formulation Performance Indicator Results</td></tr><tr><td style="white-space:nowrap">BioburdenReductionFiltrationProcessParameterResultsStep<a name="manufacturing-step-BioburdenReductionFiltrationProcessParameterResultsStep"> </a></td><td>Bioburden Reduction Filtration Process Parameter Results</td></tr><tr><td style="white-space:nowrap">BioburdenReductionFiltrationPerformanceIndicatorResultsStep<a name="manufacturing-step-BioburdenReductionFiltrationPerformanceIndicatorResultsStep"> </a></td><td>Bioburden Reduction Filtration Performance Indicator Results</td></tr><tr><td style="white-space:nowrap">MediaChallengeHoldTimesStep<a name="manufacturing-step-MediaChallengeHoldTimesStep"> </a></td><td>Media Challenge Hold Times</td></tr><tr><td style="white-space:nowrap">MediaChallengeResultsStep<a name="manufacturing-step-MediaChallengeResultsStep"> </a></td><td>Media Challenge Results</td></tr><tr><td style="white-space:nowrap">FilteredFormulatedDrugProductPerformanceIndicatorResultsStep<a name="manufacturing-step-FilteredFormulatedDrugProductPerformanceIndicatorResultsStep"> </a></td><td>Filtered Formulated Drug Product Performance Indicator Results</td></tr><tr><td style="white-space:nowrap">FillWeightSummaryStep<a name="manufacturing-step-FillWeightSummaryStep"> </a></td><td>Fill Weight Summary</td></tr><tr><td style="white-space:nowrap">FillingHomogeneityQualityAttributesStep<a name="manufacturing-step-FillingHomogeneityQualityAttributesStep"> </a></td><td>Filling Homogeneity Quality Attributes</td></tr><tr><td style="white-space:nowrap">FillingResultsSummaryStep<a name="manufacturing-step-FillingResultsSummaryStep"> </a></td><td>Filling Results Summary</td></tr><tr><td style="white-space:nowrap">StatisticalEvaluationOfHomogeneityDataStep<a name="manufacturing-step-StatisticalEvaluationOfHomogeneityDataStep"> </a></td><td>Statistical Evaluation of Homogeneity Data</td></tr><tr><td style="white-space:nowrap">ConsistencyoftheLyophilizationProcessStep<a name="manufacturing-step-ConsistencyoftheLyophilizationProcessStep"> </a></td><td>Consistency of the Lyophilization Process</td></tr><tr><td style="white-space:nowrap">LyophilizationHomogeneityStep<a name="manufacturing-step-LyophilizationHomogeneityStep"> </a></td><td>Lyophilization Homogeneity Results</td></tr></table></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="brr"/>
      </extension>
      <url value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:oid:2.16.840.1.113883.4.642.40.41.16.20"/>
      </identifier>
      <version value="1.0.0"/>
      <name value="CsManufacturingStep"/>
      <title value="Manufacturing Step Codes"/>
      <status value="active"/>
      <experimental value="false"/>
      <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="This code system contains codes for manufacturing step."/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
        <text value="World"/>
      </jurisdiction>
      <caseSensitive value="true"/>
      <content value="complete"/>
      <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>
    </CodeSystem>