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" : "CodeSystem",
"id" : "cs-manufacturingStep-local-pq",
"text" : {
"status" : "generated",
"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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"version" : "1.0.0-ballot",
"name" : "CsManufacturingStepPQ",
"title" : "CodeSystem - 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 code system 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"
}
],
"caseSensitive" : true,
"content" : "complete",
"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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