Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
| Active as of 2024-05-08 |
Generated Narrative: PlanDefinition
Resource PlanDefinition "plandefinition-drug-pq-ex1-validation-protocol"
Profile: PlanDefinition - Drug PQ
url: http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol
identifier: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.1
version: 1.0.0
title: DP PROCESS VALIDATION
type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#process-validation "Process Validation")
status: active
subject: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
date: 2024-05-08 12:53:57+0000
publisher: HL7 International / Biomedical Research and Regulation
contact: HL7 International - Biomedical Research and Regulation: http://www.hl7.org/Special/committees/rcrim
description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
jurisdiction: World (m49.htm#001)
action
title: Formulation Buffer Preparation Process Parameter Step
code: Formulation Buffer Preparation Process Parameter Step (Manufacturing Step Codes#FormulationBufferPreparationProcessParameterStep)
action
title: Formulation Buffer Preparation Process Parameter Step
code: FormulationBufferPreparationProcessParameterStep ()
action
action
action
action
title: Formulation Buffer Preparation Performance Indicator Results
code: Formulation Buffer Preparation Performance Indicator Results (Manufacturing Step Codes#FormulationBufferPreparationPerformanceIndicatorStep)
action
title: ???
code: ??? ()
action
action
action
action
action
action
title: Thawing and Formulation Process Parameter Results
code: Thawing and Formulation Process Parameter Resultss (Manufacturing Step Codes#ThawingandFormulationProcessParameterResultsStep)
action
title: ???
code: ??? ()
action
action
action
action
action
title: Thawing and Formulation Performance Indicator Results
code: Thawing and Formulation Performance Indicator Results (Manufacturing Step Codes#ThawingandFormulationPerformanceIndicatorResultsStep)
action
title: ???
code: ??? ()
action
action
action
action
action
action
title: Bioburden Reduction Filtration Process Parameter Results
code: Bioburden Reduction Filtration Process Parameter Results (Manufacturing Step Codes#BioburdenReductionFiltrationProcessParameterResultsStep)
Actions
Code Definition[x] Test () http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434
action
title: Bioburden Reduction Filtration Performance Indicator Results
code: Bioburden Reduction Filtration Performance Indicator Results (Manufacturing Step Codes#BioburdenReductionFiltrationPerformanceIndicatorResultsStep)
Actions
action
title: Media Challenge Hold Times
code: Media Challenge Hold Times (Manufacturing Step Codes#MediaChallengeHoldTimesStep)
Actions
Code Definition[x] Test () http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434
action
title: Media Challenge Results
code: Media Challenge Results (Manufacturing Step Codes#MediaChallengeResultsStep)
Actions
action
title: Filtered Formulated Drug Product Performance Indicator Results
code: Filtered Formulated Drug Product Performance Indicator Results (Manufacturing Step Codes#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep)
Actions
action
title: Fill Weight Summary
code: Fill Weight Summary (Manufacturing Step Codes#FillWeightSummaryStep)
Actions
Code Definition[x] Test () http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524
action
title: Filling Homogeneity Quality Attributes
code: Filling Homogeneity Quality Attributes (Manufacturing Step Codes#FillingHomogeneityQualityAttributesStep)
Actions
Code Definition[x] Conclusion () http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424
action
title: Filling Results Summary
code: Filling Results Summary (Manufacturing Step Codes#FillingResultsSummaryStep)
Actions
action
title: Statistical Evaluation of Homogeneity Data
code: Statistical Evaluation of Homogeneity Data (Manufacturing Step Codes#StatisticalEvaluationOfHomogeneityDataStep)
Actions
action
title: Consistency of the Lyophilization Process
code: Consistency of the Lyophilization Process (Manufacturing Step Codes#ConsistencyoftheLyophilizationProcessStep)
Actions
Code Definition[x] Test () http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 Definition () Lyophilization
action
title: Lyophilization Homogeneity
code: Lyophilization Homogeneity Results (Manufacturing Step Codes#LyophilizationHomogeneityStep)
Actions
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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QA Report
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