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

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• XML
• JSON
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: Stability Monitoring Program

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{
  "resourceType" : "PlanDefinition",
  "id" : "plandefinition-drug-pq-ex5-stability-study-protocol",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
    ]
  },
  "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\">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>"
  },
  "url" : "http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.41.34.5"
    }
  ],
  "version" : "1.0.0",
  "title" : "Stability Monitoring Program",
  "type" : {
    "coding" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type",
        "code" : "1244588",
        "display" : "Stability Study Protocol"
      }
    ]
  },
  "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 Stability Study",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "action" : [
    {
      "title" : "Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg",
      "action" : [
        {
          "title" : "Long-Term",
          "description" : "25°C/60% RH",
          "action" : [
            {
              "title" : "Initial",
              "timingTiming" : {
                "repeat" : {
                  "boundsRange" : {
                    "low" : {
                      "value" : 0,
                      "unit" : "months",
                      "system" : "http://unitsofmeasure.org",
                      "code" : "mo"
                    },
                    "high" : {
                      "value" : 0,
                      "unit" : "months",
                      "system" : "http://unitsofmeasure.org",
                      "code" : "mo"
                    }
                  },
                  "frequency" : 1
                }
              },
              "action" : [
                {
                  "title" : "XYZ",
                  "definitionCanonical" : "http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"
                }
              ]
            }
          ]
        }
      ]
    }
  ]
}