Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

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. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

CodeSystem: CodeSystem - Manufacturing Step

Official URL: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq Version: 1.0.0-ballot
Active as of 2023-12-18 Computable Name: CsManufacturingStepPQ

This code system contains example codes for manufacturing step in PQ.

This Code system is referenced in the content logical definition of the following value sets:

This case-sensitive code system http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq defines the following codes:

CodeDisplay
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