Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, 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="2024-05-08T13:55:35+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>