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
Active as of 2023-12-18 |
<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>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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