Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.0.0-ballot 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: FinishedProduct - Mappings

Active as of 2024-04-04

Mappings for the pqcmc-product-part resource profile.

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

FinishedProduct
ManufacturedItemDefinitionadministrative.medication
   identifierFiveWs.class
   nameFiveWs.class

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

FinishedProduct
ManufacturedItemDefinitionManufactured Item
   identifiern/a
   statusn/a
   namen/a
   manufacturedDoseFormManufactured Item.Manufactured Dose Form
   unitOfPresentationManufactured Item.Unit of Presentation
   manufacturerManufactured Item.Manufacturer / Establishment (Organisation)
   marketingStatusn/a
   ingredientManufactured Item.Ingredient (see also FHIR Ingredient resource)
   propertyManufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (OvrRelsProf)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueCodeableConcept)Physical Characteristics, attribute's value
   property (OvrRelsMech)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueCodeableConcept)Physical Characteristics, attribute's value
   property (CoatInd)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueBoolean)Physical Characteristics, attribute's value
   property (LayCnt)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (BeaTypCnt)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (CapClass)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueCodeableConcept)Physical Characteristics, attribute's value
   property (CapConCnt)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (Schematic)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueAttachment)Physical Characteristics, attribute's value
   property (WgtTyp)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueCodeableConcept)Physical Characteristics, attribute's value
   property (TotWgtNum)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (TotWgtDen)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (TotWgtTxt)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (TotWgtOper)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueCodeableConcept)Physical Characteristics, attribute's value
   property (QualStd)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
      value[x] (valueCodeableConcept)Physical Characteristics, attribute's value
   componentManufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      property
      property (PPiD)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (PPiDref)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (RelsProf)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (RelsMech)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (CoatPurpose)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (Color)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (ContPercent)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (AddInfo)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value

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

FinishedProduct
ManufacturedItemDefinitionEntity, Role, or Act
   meta
      idn/a
      extensionn/a
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   manufacturedDoseForm
      idn/a
      extensionn/a
      codingunion(., ./translation)
      text./originalText[mediaType/code="text/plain"]/data
   property
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
   property (OvrRelsProf)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
      value[x] (valueCodeableConcept)
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
   property (OvrRelsMech)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
      value[x] (valueCodeableConcept)
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
   property (CoatInd)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
      value[x] (valueBoolean)
   property (LayCnt)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
         idn/a
         extensionn/a
         valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
         comparatorIVL properties
         unitPQ.unit
         systemCO.codeSystem, PQ.translation.codeSystem
         codePQ.code, MO.currency, PQ.translation.code
   property (BeaTypCnt)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
         idn/a
         extensionn/a
         valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
         comparatorIVL properties
         unitPQ.unit
         systemCO.codeSystem, PQ.translation.codeSystem
         codePQ.code, MO.currency, PQ.translation.code
   property (CapClass)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
      value[x] (valueCodeableConcept)
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
   property (CapConCnt)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
         idn/a
         extensionn/a
         valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
         comparatorIVL properties
         unitPQ.unit
         systemCO.codeSystem, PQ.translation.codeSystem
         codePQ.code, MO.currency, PQ.translation.code
   property (Schematic)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
      value[x] (valueAttachment)
   property (WgtTyp)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
      value[x] (valueCodeableConcept)
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
   property (TotWgtNum)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
         idn/a
         extensionn/a
         valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
         comparatorIVL properties
         unitPQ.unit
         systemCO.codeSystem, PQ.translation.codeSystem
         codePQ.code, MO.currency, PQ.translation.code
   property (TotWgtDen)
      idn/a
      extensionn/a
      modifierExtensionN/A
      value[x]
         idn/a
         extensionn/a
         valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
         comparatorIVL properties
         unitPQ.unit
         systemCO.codeSystem, PQ.translation.codeSystem
         codePQ.code, MO.currency, PQ.translation.code
   property (TotWgtTxt)
      idn/a
      extensionn/a
      modifierExtensionN/A
   property (TotWgtOper)
      idn/a
      extensionn/a
      modifierExtensionN/A
   property (QualStd)
      idn/a
      extensionn/a
      modifierExtensionN/A
   component
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      function
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      amount
         idn/a
         extensionn/a
         valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
         comparatorIVL properties
         unitPQ.unit
         systemCO.codeSystem, PQ.translation.codeSystem
         codePQ.code, MO.currency, PQ.translation.code
      constituent
         idn/a
         modifierExtensionN/A
         amount
            idn/a
            extensionn/a
            valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
            comparatorIVL properties
            unitPQ.unit
            systemCO.codeSystem, PQ.translation.codeSystem
            codePQ.code, MO.currency, PQ.translation.code
         location
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         function
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         function (Category)
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         function (Function)
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property
      property (PPiD)
         idn/a
         extensionn/a
         modifierExtensionN/A
         value[x]
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property (PPiDref)
         idn/a
         extensionn/a
         modifierExtensionN/A
         value[x]
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property (RelsProf)
         idn/a
         extensionn/a
         modifierExtensionN/A
         value[x]
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property (RelsMech)
         idn/a
         extensionn/a
         modifierExtensionN/A
         value[x]
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property (CoatPurpose)
         idn/a
         extensionn/a
         modifierExtensionN/A
         value[x]
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property (Color)
         idn/a
         extensionn/a
         modifierExtensionN/A
         value[x]
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property (ContPercent)
         idn/a
         extensionn/a
         modifierExtensionN/A
      property (AddInfo)
         idn/a
         extensionn/a
         modifierExtensionN/A