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 |
{
"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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex2-manufacturing-plan\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p><p style=\"margin-bottom: 0px\">Tag: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ObservationValue http://terminology.hl7.org/CodeSystem/v3-ObservationValue}\">http://terminology.hl7.org/CodeSystem/v3-ObservationValue</span></p></div><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan</code></p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: Process 1.0</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#manufacturing-process "Manufacturing Process")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1</a></p><p><b>date</b>: 2023-12-18 16:00:45+0000</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International - Biomedical Research and Regulation: <a href=\"http://www.hl7.org/Special/committees/rcrim\">http://www.hl7.org/Special/committees/rcrim</a></p><p><b>description</b>: Narrative description of manufacturing process (5)</p><p><b>jurisdiction</b>: World <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (m49.htm#001)</span></p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-pH</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - pH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>pH must be in range 6.9 to 7.1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH "pH")</span></td><td>6.9-7.1 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-water-content</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 2% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent "Water content")</span></td><td>?-2</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-particle-size</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 200 microns <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#particle-size "Particle Size")</span></td><td>?-200</td></tr></table></blockquote></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://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "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" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq",
"code" : "manufacturing-process",
"display" : "Manufacturing Process"
}
]
},
"status" : "active",
"subjectReference" : {
🔗 "reference" : "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
},
"date" : "2023-12-18T16:00:45+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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : {
"text" : "Controls - pH"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : {
"text" : "Controls - Water Content"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water content"
}
],
"text" : "Under 2%"
},
"detailRange" : {
"high" : {
"value" : 2,
"unit" : "%"
}
}
}
]
},
{
"id" : "goal-control-particle-size",
"category" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : {
"text" : "Controls - Particle Size"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "particle-size",
"display" : "Particle Size"
}
],
"text" : "Under 200 microns"
},
"detailRange" : {
"high" : {
"value" : 200,
"unit" : "microns"
}
}
}
]
}
]
}
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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