Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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

## 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

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