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: BatchFormulaMedicinalProduct - Mappings

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

Mappings for the pqcmc-batch-formula-product 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
--- | --- | --- | ---
MedicinalProductDefinition | administrative.medication | Medicinal Product and Investigational Medicinal Product | Entity Role or Act ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
id |  |  |
meta |  |  |
implicitRules |  |  |
language |  |  |
text |  |  | Act.text?
contained |  |  | N/A
extension |  |  | N/A
modifierExtension |  |  | N/A
identifier | FiveWs.class | Medicinal Product.MPID Investigational Medicinal Product.IMPID | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
type |  | (indicates if this is Medicinal Product or an Investigational Medicinal Product) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code
domain |  | n/a | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value
version |  | Medicinal Product.Header.Version Number | n/a
status |  | n/a | n/a
statusDate |  | n/a | n/a
description |  | n/a | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc
combinedPharmaceuticalDoseForm |  | Medicinal Product.Combined Pharmaceutical Dose Form | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode
route |  | Pharmaceutical Product.Route of Administration | ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode
indication |  | (roll up of all text in Therapeutic Indication.Indication Text for common case where information is not granular) | ManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value
legalStatusOfSupply |  | Marketing Authorisation.Legal Status of Supply (moved here for practicality) | ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code
additionalMonitoringIndicator |  | Medicinal Product.Additional Monitoring Indicator | ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
specialMeasures |  | Medicinal Product.Special Measures | ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName
pediatricUseIndicator |  | Medicinal Product.Pediatric Use Indicator | ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
classification |  | Product Classification.Value | ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code
marketingStatus |  | Marketing Status | ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode
packagedMedicinalProduct |  | Packaged Medicinal Product | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code
comprisedOf |  | Manufactured Item | ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode
ingredient |  | Medicinal Product.Ingredient (see also FHIR Ingredient resource) | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code
impurity |  | n/a | (to do)
attachedDocument |  | Attached Document | ManufacturedProduct[classCode='MANU'].subjectOf.document
masterFile |  | Master File | ManufacturedProduct[classCode='MANU'].subjectOf.document
contact |  | n/a | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
type |  | n/a | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code
contact |  | n/a | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
clinicalTrial |  | Investigational Medicinal Product.Clinical Trial Status | ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram
code |  | n/a | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
Slices for name |  | Medicinal Product Name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
name:All Slices |  |  |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
productName |  | Medicinal Product Name.Full Name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
type |  | n/a | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
usage |  | Country / Language | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
country |  | Country / Language.Country | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
jurisdiction |  | Country / Language.Jurisdiction | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
language |  | Country / Language.Language | lang
name:Proprietary |  | Medicinal Product Name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
productName |  | Medicinal Product Name.Full Name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
type |  | n/a | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
usage |  | Country / Language | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
country |  | Country / Language.Country | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
jurisdiction |  | Country / Language.Jurisdiction | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
language |  | Country / Language.Language | lang
name:NonProprietary |  | Medicinal Product Name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
productName |  | Medicinal Product Name.Full Name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
type |  | n/a | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
Slices for part |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
part:All Slices |  |  |
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part:Scientific |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part:Invented |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part:Formulation |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part:Strength |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
id |  |  | n/a
extension |  |  | n/a
coding |  |  | union(. ./translation)
text |  |  | ./originalText[mediaType/code="text/plain"]/data
part:Container |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part:Form |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part:Device |  | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
part |  | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type |  | (which of the name parts this is e.g. Formulation Part) | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
usage |  | Country / Language | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
country |  | Country / Language.Country | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
jurisdiction |  | Country / Language.Jurisdiction | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
language |  | Country / Language.Language | lang
crossReference |  | Product Cross-Reference | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
product |  | Product Cross-Reference | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code
type |  | Product Cross-Reference | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code
operation |  | Manufacturing / Business Operation | ManufacturedProduct[classCode='MANU'].subjectOf.action
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
type |  | Manufacturing / Business Operation.Operation Type | ManufacturedProduct[classCode='MANU'].subjectOf.action.code
effectiveDate |  | Manufacturing / Business Operation.Effective Date | ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime
organization |  | Manufacturer / Establishment (Organisation) | ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation
confidentialityIndicator |  | Manufacturing / Business Operation.Confidentiality Indicator | ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode
characteristic |  | Package Item (Container).Physical Characteristics | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic
id |  |  | n/a
extension |  |  | n/a
modifierExtension |  |  | N/A
type |  | Physical Characteristics all attributes | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']
value[x] |  | Physical Characteristics attribute's value | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value
Documentation for this format