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: DrugProductIngredient - Mappings

Page standards status: Trial-use | Maturity Level: 2

Mappings for the pqcmc-dp-ingredient 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
--- | --- | --- | ---
Ingredient | administrative.medication | Ingredient | 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 |
for |  | n/a |
role |  | Ingredient.Ingredient Role |
function |  | n/a |
group |  | n/a |
allergenicIndicator |  | Ingredient.Allergenic Indicator |
comment |  | n/a |
manufacturer |  | Ingredient.manufacturer |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
role |  | Ingredient.Manufacturer / Establishment (Organisation) |
manufacturer |  | Ingredient.Manufacturer / Establishment (Organisation) |
substance |  | Ingredient.Substance |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
code |  | Substance.Substance |
Slices for strength |  | Specified Substance.Strength |
strength:All Slices |  |  |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
presentation[x] |  | Strength.Strength (Presentation) |
textPresentation |  | n/a |
concentration[x] |  | Strength.Strength (Concentration) |
textConcentration |  | n/a |
basis |  | n/a |
measurementPoint |  | Strength.Measurement Point |
country |  | Strength.Country |
referenceStrength |  | Strength.Reference Strength |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
substance |  | Reference Strength.Reference Substance |
strength[x] |  | Reference Strength.Reference Strength |
measurementPoint |  | Reference Strength.Measurement Point |
country |  | Reference Strength.Country |
strength:perBatch |  | Specified Substance.Strength |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
presentation[x] |  | Strength.Strength (Presentation) |
textPresentation |  | n/a |
concentration[x] |  | Strength.Strength (Concentration) |
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
textConcentration |  | n/a |
basis |  | n/a |
measurementPoint |  | Strength.Measurement Point |
country |  | Strength.Country |
referenceStrength |  | Strength.Reference Strength |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
substance |  | Reference Strength.Reference Substance |
strength[x] |  | Reference Strength.Reference Strength |
measurementPoint |  | Reference Strength.Measurement Point |
country |  | Reference Strength.Country |
strength:percent |  | Specified Substance.Strength |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
presentation[x] |  | Strength.Strength (Presentation) |
textPresentation |  | n/a |
concentration[x] |  | Strength.Strength (Concentration) |
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
textConcentration |  | n/a |
basis |  | n/a |
measurementPoint |  | Strength.Measurement Point |
country |  | Strength.Country |
referenceStrength |  | Strength.Reference Strength |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
substance |  | Reference Strength.Reference Substance |
strength[x] |  | Reference Strength.Reference Strength |
measurementPoint |  | Reference Strength.Measurement Point |
country |  | Reference Strength.Country |
Documentation for this format