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Packagehl7.fhir.uv.pharm-quality
Resource TypePackagedProductDefinition
IdPackagedProductDefinition-packagedproductdefinition-drug-pq-ex1.json
FHIR VersionR5

Resources that use this resource

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Resources that this resource uses

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Narrative

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

Generated Narrative: PackagedProductDefinition

Resource PackagedProductDefinition "packagedproductdefinition-drug-pq-ex1"

Profile: PackagedProductDefinition - Drug PQ

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

description: The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap. Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’.

packaging

type: Box (Packaging Type#100000073498)

material: Cardboard (Package Material#200000003529)

ShelfLifeStorages

-Period[x]
*2 year (Details: UCUM code a = 'a')

manufacturer: Organization/organization-drug-pq-ex1 "AAA Molybdenum Products, Inc."

property

type: Functional (Package Property Codes#Functional)

value: false

property

type: Quality Standard (Package Property Codes#Quality Standard)

value: USP <661> Plastic Packaging Systems and Their Materials of Construction (Package Grade Codes#USP)

packaging

type: Tape (Example Local Codes - Drug#1d2344)

componentPart: true

material: Plastic (Example Local Codes - Drug#200000003208)

manufacturer: Organization/organization-drug-pq-ex1 "AAA Molybdenum Products, Inc."

property

property

property

property

packaging

type: Bottle (Packaging Type#100000073497)

material: Glass (Package Material#200000003203)

manufacturer: Organization/organization-drug-pq-ex1 "AAA Molybdenum Products, Inc."

property

property

property

property

containedItem

packaging


Source1

{
  "resourceType": "PackagedProductDefinition",
  "id": "packagedproductdefinition-drug-pq-ex1",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "packageFor": [
    {
      "reference": "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
    }
  ],
  "description": "The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap.  Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’.",
  "packaging": {
    "type": {
      "coding": [
        {
          "system": "http://hl7.org/fhir/packaging-type",
          "code": "100000073498",
          "display": "Box"
        }
      ]
    },
    "material": [
      {
        "coding": [
          {
            "system": "http://hl7.org/fhir/package-material",
            "code": "200000003529",
            "display": "Cardboard"
          }
        ]
      }
    ],
    "shelfLifeStorage": [
      {
        "periodDuration": {
          "value": 2,
          "unit": "year",
          "system": "http://unitsofmeasure.org",
          "code": "a"
        }
      }
    ],
    "manufacturer": [
      {
        "reference": "Organization/organization-drug-pq-ex1"
      }
    ],
    "property": [
      {
        "type": {
          "coding": [
            {
              "system": "http://terminology.hl7.org/CodeSystem/package-property",
              "code": "Functional",
              "display": "Functional"
            }
          ]
        },
        "valueBoolean": false
      },
      {
        "type": {
          "coding": [
            {
              "system": "http://terminology.hl7.org/CodeSystem/package-property",
              "code": "Quality Standard",
              "display": "Quality Standard"
            }
          ]
        },
        "valueCodeableConcept": {
          "coding": [
            {
              "system": "http://terminology.hl7.org/CodeSystem/package-grade",
              "code": "USP",
              "display": "USP <661> Plastic Packaging Systems and Their Materials of Construction"
            }
          ]
        }
      }
    ],
    "packaging": [
      {
        "type": {
          "coding": [
            {
              "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code": "1d2344",
              "display": "Tape"
            }
          ]
        },
        "componentPart": true,
        "material": [
          {
            "coding": [
              {
                "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                "code": "200000003208",
                "display": "Plastic"
              }
            ]
          }
        ],
        "manufacturer": [
          {
            "reference": "Organization/organization-drug-pq-ex1"
          }
        ],
        "property": [
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "Quality Specification",
                  "display": "Quality Specification"
                }
              ]
            },
            "valueCodeableConcept": {
              "text": "Quality Specification for closure is described"
            }
          },
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "Quality Standard",
                  "display": "Quality Standard"
                }
              ]
            },
            "valueCodeableConcept": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-grade",
                  "code": "BP",
                  "display": "Closure Quality Standard"
                }
              ]
            }
          },
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "Narrative",
                  "display": "Narrative"
                }
              ]
            },
            "valueCodeableConcept": {
              "text": "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"
            }
          },
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "1123ss",
                  "display": "Integrity Test"
                }
              ]
            },
            "valueCodeableConcept": {
              "text": "Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."
            }
          }
        ]
      },
      {
        "type": {
          "coding": [
            {
              "system": "http://hl7.org/fhir/packaging-type",
              "code": "100000073497",
              "display": "Bottle"
            }
          ]
        },
        "material": [
          {
            "coding": [
              {
                "system": "http://hl7.org/fhir/package-material",
                "code": "200000003203",
                "display": "Glass"
              }
            ]
          }
        ],
        "manufacturer": [
          {
            "reference": "Organization/organization-drug-pq-ex1"
          }
        ],
        "property": [
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "Quality Specification",
                  "display": "Quality Specification"
                }
              ]
            },
            "valueCodeableConcept": {
              "text": "Quality Specification is described"
            }
          },
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "Quality Standard",
                  "display": "Quality Standard"
                }
              ]
            },
            "valueCodeableConcept": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-grade",
                  "code": "USP",
                  "display": "USP <661> Plastic Packaging Systems and Their Materials of Construction"
                }
              ]
            }
          },
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "Narrative",
                  "display": "Narrative"
                }
              ]
            },
            "valueCodeableConcept": {
              "text": "Suitability, protection, safety: conformance to criteria, performance, compabilitity"
            }
          },
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/package-property",
                  "code": "Container Size",
                  "display": "Container Size"
                }
              ]
            },
            "valueQuantity": {
              "value": 250,
              "unit": "ml"
            }
          }
        ],
        "containedItem": [
          {
            "item": {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
                  "valueCode": "unsupported"
                }
              ]
            },
            "amount": {
              "value": 100,
              "unit": "mg"
            }
          }
        ],
        "packaging": [
          {
            "type": {
              "coding": [
                {
                  "system": "http://terminology.hl7.org/CodeSystem/container-closure-type",
                  "code": "Child Proof Cap",
                  "display": "Child Proof Cap"
                }
              ]
            },
            "componentPart": true,
            "material": [
              {
                "coding": [
                  {
                    "system": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                    "code": "112344ss",
                    "display": "PVC"
                  }
                ]
              }
            ],
            "manufacturer": [
              {
                "reference": "Organization/organization-drug-pq-ex1"
              }
            ],
            "property": [
              {
                "type": {
                  "coding": [
                    {
                      "system": "http://terminology.hl7.org/CodeSystem/package-property",
                      "code": "Quality Specification",
                      "display": "Quality Specification"
                    }
                  ]
                },
                "valueCodeableConcept": {
                  "text": "Quality Specification for closure is described"
                }
              },
              {
                "type": {
                  "coding": [
                    {
                      "system": "http://terminology.hl7.org/CodeSystem/package-property",
                      "code": "Quality Standard",
                      "display": "Quality Standard"
                    }
                  ]
                },
                "valueCodeableConcept": {
                  "coding": [
                    {
                      "system": "http://terminology.hl7.org/CodeSystem/package-grade",
                      "code": "BP",
                      "display": "Closure Quality Standard"
                    }
                  ]
                }
              },
              {
                "type": {
                  "coding": [
                    {
                      "system": "http://terminology.hl7.org/CodeSystem/package-property",
                      "code": "Narrative",
                      "display": "Narrative"
                    }
                  ]
                },
                "valueCodeableConcept": {
                  "text": "Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"
                }
              },
              {
                "type": {
                  "coding": [
                    {
                      "system": "http://terminology.hl7.org/CodeSystem/package-property",
                      "code": "1123ss",
                      "display": "Integrity Test"
                    }
                  ]
                },
                "valueCodeableConcept": {
                  "text": "Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."
                }
              }
            ]
          }
        ]
      }
    ]
  }
}