Pharmaceutical Quality (Industry)
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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

: Stability Monitoring Program

Active as of 2026-05-10

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:PlanDefinition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "plandefinition-drug-pq-ex5-stability-study-protocol"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<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\">Stability Monitoring Program</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:2.16.840.1.113883.4.642.40.41.34.5</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 Stability Study</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    Stability Study Protocol\n\n\n</td>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n  \n    \n    \n      \n      \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Long-Term</td>\n\n\n</tr>\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>25°C/60% RH</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n  \n    \n    \n      \n      \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Long-Term)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Initial</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Timing</th>\n\n\n\n<td class=\"content-container\">Once</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n  \n    \n    \n      \n      \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Initial)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">XYZ</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90</code></td>\n\n\n</tr>\n\n\n\n\n\n    \n  \n\n    \n  \n\n    \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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"^^xsd:anyURI ;
fhir:l <http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol>
  ] ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986>     ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.41.34.5" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0.0"] ; # 
  fhir:title [ fhir:v "Stability Monitoring Program"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type>       ] ;
fhir:code [ fhir:v "1244588" ] ;
fhir:display [ fhir:v "Stability Study Protocol" ]     ] )
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:subject [
a fhir:Reference ;
fhir:l fhir:MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 ;
fhir:reference [ fhir:v "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" ]
  ] ; # 
  fhir:date [ fhir:v "2026-05-10T20:32:51+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Narrative description of Stability Study"] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [
fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm>       ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ]     ] )
  ] ) ; # 
  fhir:action ( [
fhir:title [ fhir:v "Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg" ] ;
    ( fhir:action [
fhir:title [ fhir:v "Long-Term" ] ;
fhir:description [ fhir:v "25°C/60% RH" ] ;
      ( fhir:action [
fhir:title [ fhir:v "Initial" ] ;
fhir:timing [
a fhir:Timing ;
fhir:repeat [
fhir:bounds [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org>                 ] ;
fhir:code [ fhir:v "mo" ]               ] ;
fhir:high [
fhir:value [ fhir:v "0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org>                 ] ;
fhir:code [ fhir:v "mo" ]               ]             ] ;
fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ]           ]         ] ;
        ( fhir:action [
fhir:title [ fhir:v "XYZ" ] ;
fhir:definition [
a fhir:Canonical ;
fhir:v "http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"^^xsd:anyURI ;
fhir:l <http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90>           ]         ] )       ] )     ] )
  ] ) . #