Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

## Resource Profile: MedicinalProductDefinitionDrugProductPq - Mappings

Active as of 2024-05-08

Mappings for the MedicinalProductDefinition-drug-product-pq resource profile.

### Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

MedicinalProductDefinitionDrugProductPq
MedicinalProductDefinition | administrative.medication
identifier | FiveWs.class

### Mappings for IDMP Mapping (https://www.iso.org/obp/ui/#iso:std:iso:11615)

MedicinalProductDefinitionDrugProductPq
MedicinalProductDefinition | Medicinal Product and Investigational Medicinal Product
identifier | Medicinal Product.MPID, Investigational Medicinal Product.IMPID
type | (indicates if this is Medicinal Product or an Investigational Medicinal Product)
domain | n/a
version | Medicinal Product.Header.Version Number
status | n/a
statusDate | n/a
description | n/a
combinedPharmaceuticalDoseForm | Medicinal Product.Combined Pharmaceutical Dose Form
route | Pharmaceutical Product.Route of Administration
indication | (roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
legalStatusOfSupply | Marketing Authorisation.Legal Status of Supply (moved here for practicality)
additionalMonitoringIndicator | Medicinal Product.Additional Monitoring Indicator
specialMeasures | Medicinal Product.Special Measures
pediatricUseIndicator | Medicinal Product.Pediatric Use Indicator
classification | Product Classification.Value
marketingStatus | Marketing Status
packagedMedicinalProduct | Packaged Medicinal Product
comprisedOf | Manufactured Item
ingredient | Medicinal Product.Ingredient (see also FHIR Ingredient resource)
impurity | n/a
attachedDocument | Attached Document
masterFile | Master File
contact | n/a
type | n/a
contact | n/a
clinicalTrial | Investigational Medicinal Product.Clinical Trial Status
code | n/a
name | Medicinal Product Name
productName | Medicinal Product Name.Full Name
type | n/a
part | (any and all of the name parts e.g. Medicinal Product Name.Formulation Part)
part | (text of any of the name parts e.g. Medicinal Product Name.Formulation Part)
type | (which of the name parts this is e.g. Formulation Part)
usage | Country / Language
country | Country / Language.Country
jurisdiction | Country / Language.Jurisdiction
language | Country / Language.Language
crossReference | Product Cross-Reference
product | Product Cross-Reference
type | Product Cross-Reference
operation | Manufacturing / Business Operation
type | Manufacturing / Business Operation.Operation Type
effectiveDate | Manufacturing / Business Operation.Effective Date
organization | Manufacturer / Establishment (Organisation)
confidentialityIndicator | Manufacturing / Business Operation.Confidentiality Indicator
characteristic | Package Item (Container).Physical Characteristics
type | Physical Characteristics, all attributes
value[x] | Physical Characteristics, attribute's value
value[x] (valueQuantity) | Physical Characteristics, attribute's value
value[x] (valueCodeableConcept) | Physical Characteristics, attribute's value

### Mappings for RIM Mapping (http://hl7.org/v3)

MedicinalProductDefinitionDrugProductPq
MedicinalProductDefinition | Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
text | Act.text?
contained | N/A
extension | N/A
modifierExtension | N/A
identifier | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
type | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code
domain | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value
version | n/a
status | n/a
statusDate | n/a
description | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc
combinedPharmaceuticalDoseForm | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode
route | ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode
indication | ManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value
legalStatusOfSupply | ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code
additionalMonitoringIndicator | ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
specialMeasures | ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName
pediatricUseIndicator | ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
classification | ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code
marketingStatus | ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode
packagedMedicinalProduct | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code
comprisedOf | ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode
ingredient | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code
impurity | (to do)
attachedDocument | ManufacturedProduct[classCode='MANU'].subjectOf.document
masterFile | ManufacturedProduct[classCode='MANU'].subjectOf.document
contact | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
id | n/a
extension | n/a
modifierExtension | N/A
type | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code
contact | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
clinicalTrial | ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram
code | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
id | n/a
extension | n/a
modifierExtension | N/A
productName | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
type | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id | n/a
extension | n/a
modifierExtension | N/A
part | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
usage | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
id | n/a
extension | n/a
modifierExtension | N/A
country | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
jurisdiction | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
language | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang
crossReference | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity
id | n/a
extension | n/a
modifierExtension | N/A
product | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code
type | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code
operation | ManufacturedProduct[classCode='MANU'].subjectOf.action
id | n/a
extension | n/a
modifierExtension | N/A
type | ManufacturedProduct[classCode='MANU'].subjectOf.action.code
effectiveDate | ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime
organization | ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation
confidentialityIndicator | ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode
characteristic | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic
id | n/a
modifierExtension | N/A
type | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']
value[x] | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value
value[x] (valueQuantity) | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].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
value[x] (valueCodeableConcept) | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value