Package | hl7.fhir.uv.pharm-quality |
Resource Type | PlanDefinition |
Id | plandefinition-drug-pq-ex2-manufacturing-plan |
FHIR Version | R5 |
Source | http://hl7.org/fhir/uv/pharm-quality/https://build.fhir.org/ig/HL7/uv-dx-pq/PlanDefinition-plandefinition-drug-pq-ex2-manufacturing-plan.html |
URL | http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan |
Version | 1.0.0 |
Status | active |
Date | 2024-05-08T12:53:57+00:00 |
Title | Process 1.0 |
Realm | uv |
Authority | hl7 |
Description | Narrative description of manufacturing process (5) |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
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
{ "resourceType": "PlanDefinition", "id": "plandefinition-drug-pq-ex2-manufacturing-plan", "meta": { "profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ], "tag": [ { "system": "http://terminology.hl7.org/CodeSystem/v3-ObservationValue", "code": "SUBSETTED" } ] }, "text": { "status": "extensions", "div": "<!-- snip (see above) -->" }, "extension": [ { "url": "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq", "valueMarkdown": "This can be text about the history" } ], "url": "http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan", "identifier": [ { "system": "urn:ietf:rfc:3986", "value": "urn:oid:2.16.840.1.113883.4.642.40.41.34.2" } ], "version": "1.0.0", "title": "Process 1.0", "type": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type", "code": "workflow-definition", "display": "Workflow Definition" }, { "system": "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type", "code": "manufacturing-process", "display": "Manufacturing Process" } ] }, "status": "active", "subjectReference": { "reference": "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" }, "date": "2024-05-08T12:53:57+00:00", "publisher": "HL7 International / Biomedical Research and Regulation", "contact": [ { "name": "HL7 International - Biomedical Research and Regulation", "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/rcrim" } ] } ], "description": "Narrative description of manufacturing process (5)", "jurisdiction": [ { "coding": [ { "system": "http://unstats.un.org/unsd/methods/m49/m49.htm", "code": "001", "display": "World" } ], "text": "World" } ], "goal": [ { "id": "goal-control-pH", "category": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category", "code": "C123456", "display": "Physical Property" } ] }, "description": { "text": "Controls - pH" }, "priority": { "coding": [ { "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example", "code": "critical", "display": "Critical" } ] }, "target": [ { "measure": { "coding": [ { "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example", "code": "pH", "display": "pH" } ], "text": "pH must be in range 6.9 to 7.1" }, "detailRange": { "low": { "value": 6.9, "unit": "pH" }, "high": { "value": 7.1, "unit": "pH" } } } ] }, { "id": "goal-control-water-content", "category": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category", "code": "C123456", "display": "Physical Property" } ] }, "description": { "text": "Controls - Water Content" }, "priority": { "coding": [ { "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example", "code": "critical", "display": "Critical" } ] }, "target": [ { "measure": { "coding": [ { "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example", "code": "WaterContent", "display": "Water content" } ], "text": "Under 2%" }, "detailRange": { "high": { "value": 2, "unit": "%" } } } ] }, { "id": "goal-control-particle-size", "category": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category", "code": "C123456", "display": "Physical Property" } ] }, "description": { "text": "Controls - Particle Size" }, "priority": { "coding": [ { "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example", "code": "critical", "display": "Critical" } ] }, "target": [ { "measure": { "coding": [ { "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example", "code": "particle-size", "display": "Particle Size" } ], "text": "Under 200 microns" }, "detailRange": { "high": { "value": 200, "unit": "microns" } } } ] } ] }