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

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Resource Profile: BatchFormula - Mappings

Page standards status: Trial-use Maturity Level: 2

Mappings for the pqcmc-product-batch-formula 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
.. ManufacturedItemDefinition
administrative.medication
Manufactured Item
  • Entity
  • Role
  • or Act
... id
... meta
... implicitRules
... text
Act.text?
... contained
N/A
... extension
N/A
... modifierExtension
N/A
... identifier
FiveWs.class
n/a
... status
n/a
... name
FiveWs.class
n/a
... manufacturedDoseForm
Manufactured Item.Manufactured Dose Form
... unitOfPresentation
Manufactured Item.Unit of Presentation
... manufacturer
Manufactured Item.Manufacturer / Establishment (Organisation)
... marketingStatus
n/a
... ingredient
Manufactured Item.Ingredient (see also FHIR Ingredient resource)
... Slices for property
Manufactured Item.Physical Characteristics
.... property:All Slices
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
  • Physical Characteristics
  • all attributes
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
...... text
./originalText[mediaType/code="text/plain"]/data
..... value[x]
  • Physical Characteristics
  • attribute's value
.... property:BatchSize
Manufactured Item.Physical Characteristics
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
  • Physical Characteristics
  • all attributes
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
...... text
./originalText[mediaType/code="text/plain"]/data
..... value[x]
  • Physical Characteristics
  • attribute's value
...... id
n/a
...... extension
n/a
...... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
...... comparator
IVL properties
...... unit
PQ.unit
...... system
  • CO.codeSystem
  • PQ.translation.codeSystem
...... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
.... property:BatchUtil
Manufactured Item.Physical Characteristics
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
  • Physical Characteristics
  • all attributes
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
...... text
./originalText[mediaType/code="text/plain"]/data
..... value[x]
  • Physical Characteristics
  • attribute's value
.... property:AddInfo
Manufactured Item.Physical Characteristics
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
  • Physical Characteristics
  • all attributes
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
...... text
./originalText[mediaType/code="text/plain"]/data
..... value[x]
  • Physical Characteristics
  • attribute's value
... component
Manufactured Item.Physical Characteristics
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
  • Physical Characteristics
  • all attributes
.... function
.... Slices for amount
..... amount:perBatch
...... id
n/a
...... extension
n/a
...... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
...... comparator
IVL properties
...... unit
PQ.unit
...... system
  • CO.codeSystem
  • PQ.translation.codeSystem
...... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
..... amount:percent
...... id
n/a
...... extension
n/a
...... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
...... comparator
IVL properties
...... unit
PQ.unit
...... system
  • CO.codeSystem
  • PQ.translation.codeSystem
...... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
.... constituent
..... id
n/a
..... Slices for extension
...... extension:additional-info
...... extension:ingredientOverage
...... extension:StrengthTextual
..... modifierExtension
N/A
..... Slices for amount
...... amount:perBatch
....... id
n/a
....... extension
n/a
....... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
....... comparator
IVL properties
....... unit
PQ.unit
....... system
  • CO.codeSystem
  • PQ.translation.codeSystem
....... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
...... amount:percent
....... id
n/a
....... extension
n/a
....... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
....... comparator
IVL properties
....... unit
PQ.unit
....... system
  • CO.codeSystem
  • PQ.translation.codeSystem
....... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
..... location
..... function
..... hasIngredient
.... Slices for property
..... property:All Slices
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
  • Physical Characteristics
  • all attributes
....... id
n/a
....... extension
n/a
....... coding
  • union(.
  • ./translation)
....... text
./originalText[mediaType/code="text/plain"]/data
...... value[x]
  • Physical Characteristics
  • attribute's value
..... property:PPiD
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
  • Physical Characteristics
  • all attributes
....... id
n/a
....... extension
n/a
....... coding
  • union(.
  • ./translation)
....... text
./originalText[mediaType/code="text/plain"]/data
...... value[x]
  • Physical Characteristics
  • attribute's value
..... property:PPiDref
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
  • Physical Characteristics
  • all attributes
....... id
n/a
....... extension
n/a
....... coding
  • union(.
  • ./translation)
....... text
./originalText[mediaType/code="text/plain"]/data
...... value[x]
  • Physical Characteristics
  • attribute's value
..... property:AddInfo
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... type
  • Physical Characteristics
  • all attributes
....... id
n/a
....... extension
n/a
....... coding
  • union(.
  • ./translation)
....... text
./originalText[mediaType/code="text/plain"]/data
...... value[x]
  • Physical Characteristics
  • attribute's value
.... component

doco Documentation for this format