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 2026-05-10 |
{
"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"
}
]
},
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <table class=\"narrative-table\">\n <tbody>\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">Metadata</th>\n\n\n</tr>\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Process 1.0</td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Version</th>\n\n\n\n<td class=\"content-container\">1.0.0</td>\n\n\n</tr>\n\n\n\n\n\n\n\n \n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Identifier</th>\n\n\n\n<td class=\"content-container\">urn:oid:2.16.840.1.113883.4.642.40.41.34.2</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Subject Type</th>\n\n\n\n<td class=\"content-container\"><a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Jurisdiction</th>\n\n\n\n<td class=\"content-container\">\n World\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward (Publisher)</th>\n\n\n\n<td class=\"content-container\">HL7 International / Biomedical Research and Regulation</td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward Contact</th>\n\n\n\n<td class=\"content-container\">HL7 International / Biomedical Research and Regulation</td>\n\n\n</tr>\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Description</th>\n\n\n\n<td class=\"content-container\"><div><p>Narrative description of manufacturing process (5)</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Type</th>\n\n\n\n<td class=\"content-container\">\n Workflow Definition\n\n\n Manufacturing Process\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n<tr>\n <th colspan=\"2\" scope=\"row\" class=\"row-header\">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>\n</tr>\n\n </tbody>\n </table>\n</div>"
},
"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" : "2026-05-10T20:32:51+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"
}
]
}
],
"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"
}
}
}
]
}
]
}
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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