Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Resource Profile: ContainerClosure - Mappings

Active as of 2024-12-12

Mappings for the ContainerClosure resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

ContainerClosure
PackagedProductDefinitionadministrative.medication
   identifierFiveWs.class

Mappings for IDMP Mapping (https://www.iso.org/obp/ui/#iso:std:iso:11615)

ContainerClosure
PackagedProductDefinitionPackaged Medicinal Product
   identifierPackaged Medicinal Product.PCID
   namen/a
   typen/a
   packageFor(the link from Packaged Medicinal Product to Medicinal Product)
   statusn/a
   statusDaten/a
   containedItemQuantityn/a
   descriptionPackaged Medicinal Product.description
   legalStatusOfSupplyMarketing Authorization.Legal Status of Supply (for a package)
      codeMarketing Authorization.Legal Status of Supply (for a package)
      jurisdictionn/a
   marketingStatusPackaged Medicinal Product.Marketing Status
   copackagedIndicatorn/a
   manufacturerPackaged Medicinal Product.Manufacturer / Establishment (Organisation)
   attachedDocumentn/a
   packagingPackaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)
      identifierPackage Item (Container).Data Carrier Identifier
      typePackage Item (Container).Package Item (Container) Type
      componentPartWhether this packaging item corresponds to an Package Item (Container), if false, or a Package (Component), when true
      quantityPackage Item (Container).Package Item (Container) Quantity
      materialPackage Item (Container).Material
      alternateMaterialPackage Item (Container).Alternate Material
      shelfLifeStoragePackage Item (Container).Shelf Life / Storage
      manufacturerPackage Item (Container).Manufacturer / Establishment (Organisation)
      propertyPackage Item (Container).Physical Characteristics
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      containedItemPackage Item (Container).Manufactured Item, Package Item (Container).Device
         item(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device
         amountManufactured Item.Manufactured Item Quantity
      packaging(link from Package Item (Container) to itself)
   characteristicn/a

Mappings for RIM Mapping (http://hl7.org/v3)

ContainerClosure
PackagedProductDefinitionEntity, Role, or Act
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   legalStatusOfSupply
      idn/a
      extensionn/a
      modifierExtensionN/A
   packaging
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         coding (ContainerType)union(., ./translation)
         coding (ClosureType)union(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      property
         idn/a
         extensionn/a
         modifierExtensionN/A
      containedItem
         idn/a
         extensionn/a
         modifierExtensionN/A