| Package | hl7.fhir.uv.pharm-quality |
| Resource Type | PlanDefinition |
| Id | plandefinition-drug-pq-ex1-validation-protocol |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/uv/pharm-quality/https://build.fhir.org/ig/HL7/uv-dx-pq/PlanDefinition-plandefinition-drug-pq-ex1-validation-protocol.html |
| URL | http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol |
| Version | 1.0.0 |
| Status | active |
| Date | 2024-05-08T12:53:57+00:00 |
| Title | DP PROCESS VALIDATION |
| Realm | uv |
| Authority | hl7 |
| Description | Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies... |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
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
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"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
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"identifier": [
{
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{
"title": "Media Challenge Hold Times",
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{
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}