Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
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
| Official URL: http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingStep-local-pq | Version: 1.0.0-ballot | |||
| Active as of 2023-12-18 | Computable Name: VsManufacturingStepPQ | |||
This value set contains example codes for manufacturing step in PQ.
References
http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq| Code | Display |
| Mixing of ingredients | Mixing of ingredients |
| drying | Drying |
| particleSizeReduction | Particle Size Reduction |
| overall process | Overall Process |
| compounding | Compounding Step |
| filling | Filling Step |
| lyophilization | Lyophilization Step |
| release | Release Step |
| Step1In-ProcessControlData | Step 1 In-Process Control Data |
| Step1DSReleaseTestingResults | Step 1 DS Release Testing Results |
| FormulationBufferPreparationProcessParameterStep | Formulation Buffer Preparation Process Parameter Step |
| FormulationBufferPreparationPerformanceIndicatorStep | Formulation Buffer Preparation Performance Indicator Results |
| ThawingandFormulationProcessParameterResultsStep | Thawing and Formulation Process Parameter Resultss |
| ThawingandFormulationPerformanceIndicatorResultsStep | Thawing and Formulation Performance Indicator Results |
| BioburdenReductionFiltrationProcessParameterResultsStep | Bioburden Reduction Filtration Process Parameter Results |
| BioburdenReductionFiltrationPerformanceIndicatorResultsStep | Bioburden Reduction Filtration Performance Indicator Results |
| MediaChallengeHoldTimesStep | Media Challenge Hold Times |
| MediaChallengeResultsStep | Media Challenge Results |
| FilteredFormulatedDrugProductPerformanceIndicatorResultsStep | Filtered Formulated Drug Product Performance Indicator Results |
| FillWeightSummaryStep | Fill Weight Summary |
| FillingHomogeneityQualityAttributesStep | Filling Homogeneity Quality Attributes |
| FillingResultsSummaryStep | Filling Results Summary |
| StatisticalEvaluationOfHomogeneityDataStep | Statistical Evaluation of Homogeneity Data |
| ConsistencyoftheLyophilizationProcessStep | Consistency of the Lyophilization Process |
| LyophilizationHomogeneityStep | Lyophilization Homogeneity Results |
Expansion based on codesystem CodeSystem - Manufacturing Step v1.0.0-ballot (CodeSystem)
This value set contains 25 concepts
| Code | System | Display |
| Mixing of ingredients | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Mixing of ingredients |
| drying | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Drying |
| particleSizeReduction | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Particle Size Reduction |
| overall process | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Overall Process |
| compounding | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Compounding Step |
| filling | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Filling Step |
| lyophilization | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Lyophilization Step |
| release | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Release Step |
| Step1In-ProcessControlData | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Step 1 In-Process Control Data |
| Step1DSReleaseTestingResults | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Step 1 DS Release Testing Results |
| FormulationBufferPreparationProcessParameterStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Formulation Buffer Preparation Process Parameter Step |
| FormulationBufferPreparationPerformanceIndicatorStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Formulation Buffer Preparation Performance Indicator Results |
| ThawingandFormulationProcessParameterResultsStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Thawing and Formulation Process Parameter Resultss |
| ThawingandFormulationPerformanceIndicatorResultsStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Thawing and Formulation Performance Indicator Results |
| BioburdenReductionFiltrationProcessParameterResultsStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Bioburden Reduction Filtration Process Parameter Results |
| BioburdenReductionFiltrationPerformanceIndicatorResultsStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Bioburden Reduction Filtration Performance Indicator Results |
| MediaChallengeHoldTimesStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Media Challenge Hold Times |
| MediaChallengeResultsStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Media Challenge Results |
| FilteredFormulatedDrugProductPerformanceIndicatorResultsStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Filtered Formulated Drug Product Performance Indicator Results |
| FillWeightSummaryStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Fill Weight Summary |
| FillingHomogeneityQualityAttributesStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Filling Homogeneity Quality Attributes |
| FillingResultsSummaryStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Filling Results Summary |
| StatisticalEvaluationOfHomogeneityDataStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Statistical Evaluation of Homogeneity Data |
| ConsistencyoftheLyophilizationProcessStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Consistency of the Lyophilization Process |
| LyophilizationHomogeneityStep | http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq | Lyophilization Homogeneity Results |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |
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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