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 - TTL Representation

Active as of 2024-05-08

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:CodeSystem ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "manufacturing-step"] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<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>"
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "brr" ]
      ] ) ; #
      fhir:url [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI] ; #
      fhir:identifier ( [
    fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.41.16.20" ]
      ] ) ; #
      fhir:version [ fhir:v "1.0.0"] ; #
      fhir:name [ fhir:v "CsManufacturingStep"] ; #
      fhir:title [ fhir:v "Manufacturing Step Codes"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:experimental [ fhir:v "false"^^xsd:boolean] ; #
      fhir:date [ fhir:v "2024-05-08T12:53:57+00:00"^^xsd:dateTime] ; #
      fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
      fhir:contact ( [
    fhir:name [ fhir:v "HL7 International - Biomedical Research and Regulation" ] ;
        ( fhir:telecom [
    fhir:system [ fhir:v "url" ] ;
    fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] )
      ] ) ; #
      fhir:description [ fhir:v "This code system contains codes for manufacturing step."] ; #
      fhir:jurisdiction ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "001" ] ;
    fhir:display [ fhir:v "World" ]     ] ) ;
    fhir:text [ fhir:v "World" ]
      ] ) ; #
      fhir:caseSensitive [ fhir:v "true"^^xsd:boolean] ; #
      fhir:content [ fhir:v "complete"] ; #
      fhir:concept ( [
    fhir:code [ fhir:v "Mixing of ingredients" ] ;
    fhir:display [ fhir:v "Mixing of ingredients" ]
      ] [
    fhir:code [ fhir:v "drying" ] ;
    fhir:display [ fhir:v "Drying" ]
      ] [
    fhir:code [ fhir:v "particleSizeReduction" ] ;
    fhir:display [ fhir:v "Particle Size Reduction" ]
      ] [
    fhir:code [ fhir:v "overall process" ] ;
    fhir:display [ fhir:v "Overall Process" ]
      ] [
    fhir:code [ fhir:v "compounding" ] ;
    fhir:display [ fhir:v "Compounding Step" ]
      ] [
    fhir:code [ fhir:v "filling" ] ;
    fhir:display [ fhir:v "Filling Step" ]
      ] [
    fhir:code [ fhir:v "lyophilization" ] ;
    fhir:display [ fhir:v "Lyophilization Step" ]
      ] [
    fhir:code [ fhir:v "release" ] ;
    fhir:display [ fhir:v "Release Step" ]
      ] [
    fhir:code [ fhir:v "Step1In-ProcessControlData" ] ;
    fhir:display [ fhir:v "Step 1 In-Process Control Data" ]
      ] [
    fhir:code [ fhir:v "Step1DSReleaseTestingResults" ] ;
    fhir:display [ fhir:v "Step 1 DS Release Testing Results" ]
      ] [
    fhir:code [ fhir:v "FormulationBufferPreparationProcessParameterStep" ] ;
    fhir:display [ fhir:v "Formulation Buffer Preparation Process Parameter Step" ]
      ] [
    fhir:code [ fhir:v "FormulationBufferPreparationPerformanceIndicatorStep" ] ;
    fhir:display [ fhir:v "Formulation Buffer Preparation Performance Indicator Results" ]
      ] [
    fhir:code [ fhir:v "ThawingandFormulationProcessParameterResultsStep" ] ;
    fhir:display [ fhir:v "Thawing and Formulation Process Parameter Resultss" ]
      ] [
    fhir:code [ fhir:v "ThawingandFormulationPerformanceIndicatorResultsStep" ] ;
    fhir:display [ fhir:v "Thawing and Formulation Performance Indicator Results" ]
      ] [
    fhir:code [ fhir:v "BioburdenReductionFiltrationProcessParameterResultsStep" ] ;
    fhir:display [ fhir:v "Bioburden Reduction Filtration Process Parameter Results" ]
      ] [
    fhir:code [ fhir:v "BioburdenReductionFiltrationPerformanceIndicatorResultsStep" ] ;
    fhir:display [ fhir:v "Bioburden Reduction Filtration Performance Indicator Results" ]
      ] [
    fhir:code [ fhir:v "MediaChallengeHoldTimesStep" ] ;
    fhir:display [ fhir:v "Media Challenge Hold Times" ]
      ] [
    fhir:code [ fhir:v "MediaChallengeResultsStep" ] ;
    fhir:display [ fhir:v "Media Challenge Results" ]
      ] [
    fhir:code [ fhir:v "FilteredFormulatedDrugProductPerformanceIndicatorResultsStep" ] ;
    fhir:display [ fhir:v "Filtered Formulated Drug Product Performance Indicator Results" ]
      ] [
    fhir:code [ fhir:v "FillWeightSummaryStep" ] ;
    fhir:display [ fhir:v "Fill Weight Summary" ]
      ] [
    fhir:code [ fhir:v "FillingHomogeneityQualityAttributesStep" ] ;
    fhir:display [ fhir:v "Filling Homogeneity Quality Attributes" ]
      ] [
    fhir:code [ fhir:v "FillingResultsSummaryStep" ] ;
    fhir:display [ fhir:v "Filling Results Summary" ]
      ] [
    fhir:code [ fhir:v "StatisticalEvaluationOfHomogeneityDataStep" ] ;
    fhir:display [ fhir:v "Statistical Evaluation of Homogeneity Data" ]
      ] [
    fhir:code [ fhir:v "ConsistencyoftheLyophilizationProcessStep" ] ;
    fhir:display [ fhir:v "Consistency of the Lyophilization Process" ]
      ] [
    fhir:code [ fhir:v "LyophilizationHomogeneityStep" ] ;
    fhir:display [ fhir:v "Lyophilization Homogeneity Results" ]
      ] ) . #