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-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
url: http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan
identifier: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.2
version: 1.0.0
title: Process 1.0
type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#manufacturing-process "Manufacturing Process")
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: Narrative description of manufacturing process (5)
jurisdiction: World (m49.htm#001)
goal
id
goal-control-pHcategory: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - pH ()
priority: Critical (Goal Priority - example#critical)
Targets
Measure Detail[x] pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH") 6.9-7.1 pH
goal
id
goal-control-water-contentcategory: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - Water Content ()
priority: Critical (Goal Priority - example#critical)
Targets
Measure Detail[x] Under 2% (Example Local Codes - Drug#WaterContent "Water content") ?-2
goal
id
goal-control-particle-sizecategory: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - Particle Size ()
priority: Critical (Goal Priority - example#critical)
Targets
Measure Detail[x] Under 200 microns (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 based on FHIR 5.0.0. Generated 2024-05-08
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