PlanDefinition - Drug - example, validation protocol - Pharmaceutical Quality (Industry) v1.0.0-ballot

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. . For a full list of available versions, see the Directory of published versions

Example PlanDefinition: PlanDefinition - Drug - example, validation protocol

Active as of 2023-12-18

Generated Narrative: PlanDefinition

Resource PlanDefinition "plandefinition-drug-pq-ex1-validation-protocol"

Profile: PlanDefinition - Drug PQ

StructureDefinition Work Group: brr

url: http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol

version: 1.0.0-ballot

title: DP PROCESS VALIDATION

type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#process-validation "Process Validation")

status: active

subject: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1

date: 2023-12-18 16:00:45+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 (CodeSystem - Manufacturing Step#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 (CodeSystem - Manufacturing Step#FormulationBufferPreparationPerformanceIndicatorStep)
action
title: ???
code: ??? ()
action
action
action
action
action

action
title: Thawing and Formulation Process Parameter Results
code: Thawing and Formulation Process Parameter Resultss (CodeSystem - Manufacturing Step#ThawingandFormulationProcessParameterResultsStep)
action
title: ???
code: ??? ()
action
action
action
action

action
title: Thawing and Formulation Performance Indicator Results
code: Thawing and Formulation Performance Indicator Results (CodeSystem - Manufacturing Step#ThawingandFormulationPerformanceIndicatorResultsStep)
action
title: ???
code: ??? ()
action
action
action
action
action

action
title: Bioburden Reduction Filtration Process Parameter Results
code: Bioburden Reduction Filtration Process Parameter Results (CodeSystem - Manufacturing Step#BioburdenReductionFiltrationProcessParameterResultsStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/FiltrationPressure

action
title: Bioburden Reduction Filtration Performance Indicator Results
code: Bioburden Reduction Filtration Performance Indicator Results (CodeSystem - Manufacturing Step#BioburdenReductionFiltrationPerformanceIndicatorResultsStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/PreFiltrationBioburden
* Test () ObservationDefinition/PostFiltrationFilterIntegrity

action
title: Media Challenge Hold Times
code: Media Challenge Hold Times (CodeSystem - Manufacturing Step#MediaChallengeHoldTimesStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/MediaHoldTime

action
title: Media Challenge Results
code: Media Challenge Results (CodeSystem - Manufacturing Step#MediaChallengeResultsStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/MediaBioburden
* Test () ObservationDefinition/GrowthPromotion

action
title: Filtered Formulated Drug Product Performance Indicator Results
code: Filtered Formulated Drug Product Performance Indicator Results (CodeSystem - Manufacturing Step#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/SE-UHPLCMainPeak
* Test () ObservationDefinition/SE-UHPLCMainPeakGraph
* Test () ObservationDefinition/SE-UHPLCHMW

action
title: Fill Weight Summary
code: Fill Weight Summary (CodeSystem - Manufacturing Step#FillWeightSummaryStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/FillWeight

action
title: Filling Homogeneity Quality Attributes
code: Filling Homogeneity Quality Attributes (CodeSystem - Manufacturing Step#FillingHomogeneityQualityAttributesStep)
Actions
- Code Definition[x]
* Conclusion () ObservationDefinition/conclusionHomogeneity

action
title: Filling Results Summary
code: Filling Results Summary (CodeSystem - Manufacturing Step#FillingResultsSummaryStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/ProteinConcentration
* Test () ObservationDefinition/Polysorbate80Concentration

action
title: Statistical Evaluation of Homogeneity Data
code: Statistical Evaluation of Homogeneity Data (CodeSystem - Manufacturing Step#StatisticalEvaluationOfHomogeneityDataStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/ProteinConcentrationStats
* Test () ObservationDefinition/Polysorbate80Concentration

action
title: Consistency of the Lyophilization Process
code: Consistency of the Lyophilization Process (CodeSystem - Manufacturing Step#ConsistencyoftheLyophilizationProcessStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/ResidualMoisture
* Definition () ActivityDefinition/LyophilizationAct

action
title: Lyophilization Homogeneity
code: Lyophilization Homogeneity Results (CodeSystem - Manufacturing Step#LyophilizationHomogeneityStep)
Actions
- Code Definition[x]
* Test () ObservationDefinition/SE-UHPLCMainPeakLyoph
* Test () ObservationDefinition/SE-UHPLCHMWLyoph

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
Links: Table of Contents | QA Report | Version History | | Propose a change