Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

Publication Build: This will be filled in by the publication tooling

Resource Profile: ContainerClosure - Mappings

Page standards status: Trial-use Maturity Level: 2

Mappings for the ContainerClosure resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameFiveWs Pattern MappingIDMP MappingRIM Mappingdoco
.. PackagedProductDefinition
administrative.medication
Packaged Medicinal Product
  • Entity
  • Role
  • or Act
... id
... meta
... implicitRules
... text
Act.text?
... contained
N/A
... extension
N/A
... modifierExtension
N/A
... identifier
FiveWs.class
Packaged Medicinal Product.PCID
... name
n/a
... type
n/a
... packageFor
(the link from Packaged Medicinal Product to Medicinal Product)
... status
n/a
... statusDate
n/a
... containedItemQuantity
n/a
... description
Packaged Medicinal Product.description
... legalStatusOfSupply
Marketing Authorization.Legal Status of Supply (for a package)
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... code
Marketing Authorization.Legal Status of Supply (for a package)
.... jurisdiction
n/a
... marketingStatus
Packaged Medicinal Product.Marketing Status
... copackagedIndicator
n/a
... manufacturer
Packaged Medicinal Product.Manufacturer / Establishment (Organisation)
... attachedDocument
n/a
... packaging
  • Packaged Medicinal Product.Package Item (Container)
  • Package Item (Container).Package (Component)
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... identifier
Package Item (Container).Data Carrier Identifier
.... type
Package Item (Container).Package Item (Container) Type
..... id
n/a
..... extension
n/a
..... Slices for coding
  • union(.
  • ./translation)
...... coding:ContainerType
  • union(.
  • ./translation)
...... coding:ClosureType
  • union(.
  • ./translation)
..... text
./originalText[mediaType/code="text/plain"]/data
.... componentPart
  • Whether this packaging item corresponds to an Package Item (Container)
  • if false
  • or a Package (Component)
  • when true
.... quantity
Package Item (Container).Package Item (Container) Quantity
.... material
Package Item (Container).Material
.... alternateMaterial
Package Item (Container).Alternate Material
.... shelfLifeStorage
Package Item (Container).Shelf Life / Storage
.... manufacturer
Package Item (Container).Manufacturer / Establishment (Organisation)
.... property
Package Item (Container).Physical Characteristics
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
  • Physical Characteristics
  • all attributes
..... value[x]
  • Physical Characteristics
  • attribute's value
.... containedItem
  • Package Item (Container).Manufactured Item
  • Package Item (Container).Device
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... item
  • (the link to) Package Item (Container).Manufactured Item
  • Package Item (Container).Device
..... amount
Manufactured Item.Manufactured Item Quantity
.... packaging
(link from Package Item (Container) to itself)
... characteristic
n/a

doco Documentation for this format