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
| Active as of 2023-12-18 |
Generated Narrative: PlanDefinition
Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan"
Profile: PlanDefinition - Drug PQ
Tag: http://terminology.hl7.org/CodeSystem/v3-ObservationValue
Extension - History of Process PQ: This can be text about the history
StructureDefinition Work Group: brr
url: http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan
version: 1.0.0-ballot
title: Process 1.0
type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#manufacturing-process "Manufacturing Process")
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: Narrative description of manufacturing process (5)
jurisdiction: World (m49.htm#001)
goal
id
goal-control-pHcategory: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - pH ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
Measure Detail[x] pH must be in range 6.9 to 7.1 (CodeSystem - Example Local Codes - Drug#pH "pH") 6.9-7.1 pH
goal
id
goal-control-water-contentcategory: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - Water Content ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
Measure Detail[x] Under 2% (CodeSystem - Example Local Codes - Drug#WaterContent "Water content") ?-2
goal
id
goal-control-particle-sizecategory: Physical Property (CodeSystem - Test Category#C123456)
description: Controls - Particle Size ()
priority: Critical (CodeSystem - Goal Priority#critical)
Targets
Measure Detail[x] Under 200 microns (CodeSystem - Example Local Codes - Drug#particle-size "Particle Size") ?-200
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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