Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Resource Profile: BatchFormula - Mappings

Active as of 2024-12-12

Mappings for the pqcmc-product-batch-formula resource profile.

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

BatchFormula
ManufacturedItemDefinitionadministrative.medication
   identifierFiveWs.class
   nameFiveWs.class

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

BatchFormula
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 (BatchSize)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (BatchUtil)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   property (AddInfo)Manufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value
   componentManufactured Item.Physical Characteristics
      typePhysical Characteristics, all attributes
      property
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      property (PPiD)
         typePhysical Characteristics, all attributes
      property (PPiDref)
         typePhysical Characteristics, all attributes
      property (AddInfo)
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value

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

BatchFormula
ManufacturedItemDefinitionEntity, Role, or Act
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   property
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      value[x]
   property (BatchSize)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      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 (BatchUtil)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
   property (AddInfo)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
   component
      idn/a
      extensionn/a
      modifierExtensionN/A
      amount
      amount (perBatch)
         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
      amount (percent)
         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
         amount (perBatch)
            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
         amount (percent)
            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
         hasIngredientn/a
      property
         idn/a
         extensionn/a
         modifierExtensionN/A
         type
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
      property (PPiD)
         idn/a
         extensionn/a
         modifierExtensionN/A
         type
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         value[x]n/a,CD
      property (PPiDref)
         idn/a
         extensionn/a
         modifierExtensionN/A
         type
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         value[x]n/a,CD
      property (AddInfo)
         idn/a
         extensionn/a
         modifierExtensionN/A
         type
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data