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

: PlanDefinition - Drug - example, stability study protocol - JSON Representation

Active as of 2024-04-18

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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"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex5-stability-study-protocol\"> </a><a name=\"hcplandefinition-drug-pq-ex5-stability-study-protocol\"> </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 &quot;plandefinition-drug-pq-ex5-stability-study-protocol&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol</code></p><p><b>identifier</b>: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.5</p><p><b>version</b>: 1.0.0</p><p><b>title</b>: Stability Monitoring Program</p><p><b>type</b>: Stability Study Protocol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-plan-type.html\">Pharmaceutical Plan Type Codes</a>#1244588)</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>: 2024-04-18 13:07:33+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 Stability Study</p><p><b>jurisdiction</b>: World <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (m49.htm#001)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</p><blockquote><p><b>action</b></p><p><b>title</b>: Long-Term</p><p><b>description</b>: 25°C/60% RH</p><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></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" : "2024-04-18T13:07:33+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"
        }
      ],
      "text" : "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"
                }
              ]
            }
          ]
        }
      ]
    }
  ]
}