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FHIR IG Statistics: PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan

Packagehl7.fhir.uv.pharm-quality
Resource TypePlanDefinition
Idplandefinition-drug-pq-ex2-manufacturing-plan
FHIR VersionR5
Sourcehttp://hl7.org/fhir/uv/pharm-quality/https://build.fhir.org/ig/HL7/uv-dx-pq/PlanDefinition-plandefinition-drug-pq-ex2-manufacturing-plan.html
URLhttp://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan
Version1.0.0
Statusactive
Date2024-05-08T12:53:57+00:00
TitleProcess 1.0
Realmuv
Authorityhl7
DescriptionNarrative description of manufacturing process (5)

Resources that use this resource

No resources found


Resources that this resource uses

No resources found


Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: PlanDefinition

Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan"

Profile: PlanDefinition - Drug PQ

Tag: http://terminology.hl7.org/CodeSystem/v3-ObservationValue

Extension - History of Process PQ: This can be text about the history

url: http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan

identifier: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.2

version: 1.0.0

title: Process 1.0

type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#manufacturing-process "Manufacturing Process")

status: active

subject: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1

date: 2024-05-08 12:53:57+0000

publisher: HL7 International / Biomedical Research and Regulation

contact: HL7 International - Biomedical Research and Regulation: http://www.hl7.org/Special/committees/rcrim

description: Narrative description of manufacturing process (5)

jurisdiction: World (m49.htm#001)

goal

id

goal-control-pH

category: Physical Property (Pharmaceutical Test Category Codes#C123456)

description: Controls - pH ()

priority: Critical (Goal Priority - example#critical)

Targets

-MeasureDetail[x]
*pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH")6.9-7.1 pH

goal

id

goal-control-water-content

category: Physical Property (Pharmaceutical Test Category Codes#C123456)

description: Controls - Water Content ()

priority: Critical (Goal Priority - example#critical)

Targets

-MeasureDetail[x]
*Under 2% (Example Local Codes - Drug#WaterContent "Water content")?-2

goal

id

goal-control-particle-size

category: Physical Property (Pharmaceutical Test Category Codes#C123456)

description: Controls - Particle Size ()

priority: Critical (Goal Priority - example#critical)

Targets

-MeasureDetail[x]
*Under 200 microns (Example Local Codes - Drug#particle-size "Particle Size")?-200

Source

{
  "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": "<!-- snip (see above) -->"
  },
  "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": "2024-05-08T12:53:57+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://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"
            }
          }
        }
      ]
    }
  ]
}