{ "description": "This value set contains example codes for manufacturing step in PQ.", "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" } ] } ] }, "_filename": "ValueSet-vs-manufacturingStep-local-pq.json", "package_name": "hl7.fhir.uv.pharm-quality", "date": "2023-12-18T16:00:45+00:00", "publisher": "HL7 International / Biomedical Research and Regulation", "jurisdiction": [ { "text": "World", "coding": [ { "code": "001", "system": "http://unstats.un.org/unsd/methods/m49/m49.htm", "display": "World" } ] } ], "name": "VsManufacturingStepPQ", "type": null, "experimental": "false", "resourceType": "ValueSet", "title": "ValueSet - Manufacturing Step", "package_version": "1.0.0-ballot", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" } ], "status": "active", "id": "a951a683-20be-4d6e-93be-92280cd424ee", "kind": null, "url": "http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingStep-local-pq", "version": "1.0.0-ballot", "contact": [ { "name": "HL7 International - Biomedical Research and Regulation", "telecom": [ { "value": "http://www.hl7.org/Special/committees/rcrim", "system": "url" } ] } ] }