Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

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Resource Profile: BatchFormula - Mappings

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

Name	FiveWs Pattern Mapping	IDMP Mapping	RIM Mapping
ManufacturedItemDefinition	administrative.medication	Manufactured Item	Entity Role or Act
id
meta
implicitRules
language
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
Documentation for this format