Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

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

: CodeSystem - Manufacturing Step - TTL Representation

Active as of 2023-12-18

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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 "cs-manufacturingStep-local-pq"] ; # 
  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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq</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=\"cs-manufacturingStep-local-pq-Mixingofingredients\"> </a></td><td>Mixing of ingredients</td></tr><tr><td style=\"white-space:nowrap\">drying<a name=\"cs-manufacturingStep-local-pq-drying\"> </a></td><td>Drying</td></tr><tr><td style=\"white-space:nowrap\">particleSizeReduction<a name=\"cs-manufacturingStep-local-pq-particleSizeReduction\"> </a></td><td>Particle Size Reduction</td></tr><tr><td style=\"white-space:nowrap\">overall process<a name=\"cs-manufacturingStep-local-pq-overallprocess\"> </a></td><td>Overall Process</td></tr><tr><td style=\"white-space:nowrap\">compounding<a name=\"cs-manufacturingStep-local-pq-compounding\"> </a></td><td>Compounding Step</td></tr><tr><td style=\"white-space:nowrap\">filling<a name=\"cs-manufacturingStep-local-pq-filling\"> </a></td><td>Filling Step</td></tr><tr><td style=\"white-space:nowrap\">lyophilization<a name=\"cs-manufacturingStep-local-pq-lyophilization\"> </a></td><td>Lyophilization Step</td></tr><tr><td style=\"white-space:nowrap\">release<a name=\"cs-manufacturingStep-local-pq-release\"> </a></td><td>Release Step</td></tr><tr><td style=\"white-space:nowrap\">Step1In-ProcessControlData<a name=\"cs-manufacturingStep-local-pq-Step1In-ProcessControlData\"> </a></td><td>Step 1 In-Process Control Data</td></tr><tr><td style=\"white-space:nowrap\">Step1DSReleaseTestingResults<a name=\"cs-manufacturingStep-local-pq-Step1DSReleaseTestingResults\"> </a></td><td>Step 1 DS Release Testing Results</td></tr><tr><td style=\"white-space:nowrap\">FormulationBufferPreparationProcessParameterStep<a name=\"cs-manufacturingStep-local-pq-FormulationBufferPreparationProcessParameterStep\"> </a></td><td>Formulation Buffer Preparation Process Parameter Step</td></tr><tr><td style=\"white-space:nowrap\">FormulationBufferPreparationPerformanceIndicatorStep<a name=\"cs-manufacturingStep-local-pq-FormulationBufferPreparationPerformanceIndicatorStep\"> </a></td><td>Formulation Buffer Preparation Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">ThawingandFormulationProcessParameterResultsStep<a name=\"cs-manufacturingStep-local-pq-ThawingandFormulationProcessParameterResultsStep\"> </a></td><td>Thawing and Formulation Process Parameter Resultss</td></tr><tr><td style=\"white-space:nowrap\">ThawingandFormulationPerformanceIndicatorResultsStep<a name=\"cs-manufacturingStep-local-pq-ThawingandFormulationPerformanceIndicatorResultsStep\"> </a></td><td>Thawing and Formulation Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">BioburdenReductionFiltrationProcessParameterResultsStep<a name=\"cs-manufacturingStep-local-pq-BioburdenReductionFiltrationProcessParameterResultsStep\"> </a></td><td>Bioburden Reduction Filtration Process Parameter Results</td></tr><tr><td style=\"white-space:nowrap\">BioburdenReductionFiltrationPerformanceIndicatorResultsStep<a name=\"cs-manufacturingStep-local-pq-BioburdenReductionFiltrationPerformanceIndicatorResultsStep\"> </a></td><td>Bioburden Reduction Filtration Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">MediaChallengeHoldTimesStep<a name=\"cs-manufacturingStep-local-pq-MediaChallengeHoldTimesStep\"> </a></td><td>Media Challenge Hold Times</td></tr><tr><td style=\"white-space:nowrap\">MediaChallengeResultsStep<a name=\"cs-manufacturingStep-local-pq-MediaChallengeResultsStep\"> </a></td><td>Media Challenge Results</td></tr><tr><td style=\"white-space:nowrap\">FilteredFormulatedDrugProductPerformanceIndicatorResultsStep<a name=\"cs-manufacturingStep-local-pq-FilteredFormulatedDrugProductPerformanceIndicatorResultsStep\"> </a></td><td>Filtered Formulated Drug Product Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">FillWeightSummaryStep<a name=\"cs-manufacturingStep-local-pq-FillWeightSummaryStep\"> </a></td><td>Fill Weight Summary</td></tr><tr><td style=\"white-space:nowrap\">FillingHomogeneityQualityAttributesStep<a name=\"cs-manufacturingStep-local-pq-FillingHomogeneityQualityAttributesStep\"> </a></td><td>Filling Homogeneity Quality Attributes</td></tr><tr><td style=\"white-space:nowrap\">FillingResultsSummaryStep<a name=\"cs-manufacturingStep-local-pq-FillingResultsSummaryStep\"> </a></td><td>Filling Results Summary</td></tr><tr><td style=\"white-space:nowrap\">StatisticalEvaluationOfHomogeneityDataStep<a name=\"cs-manufacturingStep-local-pq-StatisticalEvaluationOfHomogeneityDataStep\"> </a></td><td>Statistical Evaluation of Homogeneity Data</td></tr><tr><td style=\"white-space:nowrap\">ConsistencyoftheLyophilizationProcessStep<a name=\"cs-manufacturingStep-local-pq-ConsistencyoftheLyophilizationProcessStep\"> </a></td><td>Consistency of the Lyophilization Process</td></tr><tr><td style=\"white-space:nowrap\">LyophilizationHomogeneityStep<a name=\"cs-manufacturingStep-local-pq-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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "1.0.0-ballot"] ; # 
  fhir:name [ fhir:v "CsManufacturingStepPQ"] ; # 
  fhir:title [ fhir:v "CodeSystem - Manufacturing Step"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2023-12-18T16:00:45+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 example codes for manufacturing step in PQ."] ; # 
  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" ]
  ] ) . #