| 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"
}
}
}
]
}
]
}