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 |
{
"resourceType" : "ValueSet",
"id" : "vs-manufacturingStep-local-pq",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingStep-local-pq",
"version" : "1.0.0-ballot",
"name" : "VsManufacturingStepPQ",
"title" : "ValueSet - Manufacturing Step",
"status" : "active",
"experimental" : false,
"date" : "2023-12-18T16:00:45+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International - Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
}
]
}
],
"description" : "This value set contains example codes for manufacturing step in PQ.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
],
"text" : "World"
}
],
"compose" : {
"include" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"concept" : [
{
"code" : "Mixing of ingredients",
"display" : "Mixing of ingredients"
},
{
"code" : "drying",
"display" : "Drying"
},
{
"code" : "particleSizeReduction",
"display" : "Particle Size Reduction"
},
{
"code" : "overall process",
"display" : "Overall Process"
},
{
"code" : "compounding",
"display" : "Compounding Step"
},
{
"code" : "filling",
"display" : "Filling Step"
},
{
"code" : "lyophilization",
"display" : "Lyophilization Step"
},
{
"code" : "release",
"display" : "Release Step"
},
{
"code" : "Step1In-ProcessControlData",
"display" : "Step 1 In-Process Control Data"
},
{
"code" : "Step1DSReleaseTestingResults",
"display" : "Step 1 DS Release Testing Results"
},
{
"code" : "FormulationBufferPreparationProcessParameterStep",
"display" : "Formulation Buffer Preparation Process Parameter Step"
},
{
"code" : "FormulationBufferPreparationPerformanceIndicatorStep",
"display" : "Formulation Buffer Preparation Performance Indicator Results"
},
{
"code" : "ThawingandFormulationProcessParameterResultsStep",
"display" : "Thawing and Formulation Process Parameter Resultss"
},
{
"code" : "ThawingandFormulationPerformanceIndicatorResultsStep",
"display" : "Thawing and Formulation Performance Indicator Results"
},
{
"code" : "BioburdenReductionFiltrationProcessParameterResultsStep",
"display" : "Bioburden Reduction Filtration Process Parameter Results"
},
{
"code" : "BioburdenReductionFiltrationPerformanceIndicatorResultsStep",
"display" : "Bioburden Reduction Filtration Performance Indicator Results"
},
{
"code" : "MediaChallengeHoldTimesStep",
"display" : "Media Challenge Hold Times"
},
{
"code" : "MediaChallengeResultsStep",
"display" : "Media Challenge Results"
},
{
"code" : "FilteredFormulatedDrugProductPerformanceIndicatorResultsStep",
"display" : "Filtered Formulated Drug Product Performance Indicator Results"
},
{
"code" : "FillWeightSummaryStep",
"display" : "Fill Weight Summary"
},
{
"code" : "FillingHomogeneityQualityAttributesStep",
"display" : "Filling Homogeneity Quality Attributes"
},
{
"code" : "FillingResultsSummaryStep",
"display" : "Filling Results Summary"
},
{
"code" : "StatisticalEvaluationOfHomogeneityDataStep",
"display" : "Statistical Evaluation of Homogeneity Data"
},
{
"code" : "ConsistencyoftheLyophilizationProcessStep",
"display" : "Consistency of the Lyophilization Process"
},
{
"code" : "LyophilizationHomogeneityStep",
"display" : "Lyophilization Homogeneity Results"
}
]
}
]
}
}
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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