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: RoutineSubstanceDefinition - Mappings

Active as of 2024-04-04

Mappings for the pqcmc-routine-drug-substance resource profile.

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

RoutineSubstanceDefinition
SubstanceDefinitionadministrative.medication

Mappings for IDMP Mapping (Substance) (https://www.iso.org/obp/ui/#iso:std:iso:11238)

RoutineSubstanceDefinition
SubstanceDefinitionSubstance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)
   identifierSubstance.Substance_Id
   versionVersion.Version_Number
   statusn/a
   classificationSubstance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype
   domainSubstance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype
   gradeSubstance_Specified_Substance_Group_3.Grade
   descriptionSubstance.Comment
   informationSourceSubstance.Reference_Source
   noten/a
   manufacturern/a
   suppliern/a
   moietySubstance.Moiety
      roleMoiety.Moiety_Role
      identifierMoiety.Moiety_Id
      nameMoiety.Moiety_Name
      stereochemistryMoiety.Stereochemistry
      opticalActivityMoiety.Optical_Activity
      molecularFormulaMoiety.Molecular_Formula
      amount[x]Moiety.Amount
      measurementTypeAmount.Amount_Type
   characterizationn/a
      techniquen/a
      formn/a
      descriptionn/a
      filen/a
   propertySubstance.Property
      typeProperty.Property_Type
      value[x]Physical Characteristics, attribute's value
   referenceInformationReference_Information
   molecularWeight
      methodMolecular_Weight.Molecular_Weight_Method
      typeMolecular_Weight.Molecular_Weight_Type
      amountMolecular_Weight.Amount
   structureSubstance.Structure
      stereochemistryStructure.Stereochemistry
      opticalActivityStructure.Optical_Activity
      molecularFormulaStructure.Molecular_Formula
      molecularFormulaByMoietyStructure.Molecular_Formula_By_Moiety
      molecularWeightStructure.Molecular_Weight
      techniquen/a
      sourceDocumentStructure.Reference_Source
      representationStructure.Structural_Representation
         typeStructural_Representation.Structural_Representation_Type
         representationStructural_Representation.Structural_Representation
         formatn/a
         documentStructural_Representation.Structural_Representation_Attachment
   codeSubstance.Substance_Code
      codeSubstance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id
      statusSubstance_Code.Code_System_Status
      statusDateSubstance_Code.Code_Change_Date
      noteSubstance_Code.Comment
      sourceSubstance_Code.Reference_Source
   nameSubstance.Substance_Name
      nameSubstance_Name.Substance_Name
      typeSubstance_Name.Substance_Name_Type
      statusn/a
      preferredn/a
      languageSubstance_Name.Language
      domainSubstance_Name.Substance_Name_Domain
      jurisdictionSubstance_Name.Jurisdiction
      synonymn/a
      translationn/a
      officialSubstance_Name.Official_Name
         authorityOfficial_Name.Official_Name_Type
         statusOfficial_Name.Official_Name_Status
         dateOfficial_Name.Official_Name_Status_Change_Date
      sourceSubstance_Name.Reference_Source
   name (sub)Substance.Substance_Name
      nameSubstance_Name.Substance_Name
      typeSubstance_Name.Substance_Name_Type
      statusn/a
      preferredn/a
      languageSubstance_Name.Language
      domainSubstance_Name.Substance_Name_Domain
      jurisdictionSubstance_Name.Jurisdiction
      synonymn/a
      translationn/a
      officialSubstance_Name.Official_Name
         authorityOfficial_Name.Official_Name_Type
         statusOfficial_Name.Official_Name_Status
         dateOfficial_Name.Official_Name_Status_Change_Date
      sourceSubstance_Name.Reference_Source
   name (gsrs)Substance.Substance_Name
      nameSubstance_Name.Substance_Name
      typeSubstance_Name.Substance_Name_Type
      statusn/a
      preferredn/a
      languageSubstance_Name.Language
      domainSubstance_Name.Substance_Name_Domain
      jurisdictionSubstance_Name.Jurisdiction
      synonymn/a
      translationn/a
      officialSubstance_Name.Official_Name
         authorityOfficial_Name.Official_Name_Type
         statusOfficial_Name.Official_Name_Status
         dateOfficial_Name.Official_Name_Status_Change_Date
      sourceSubstance_Name.Reference_Source
   name (isbt)Substance.Substance_Name
      nameSubstance_Name.Substance_Name
      typeSubstance_Name.Substance_Name_Type
      statusn/a
      preferredn/a
      languageSubstance_Name.Language
      domainSubstance_Name.Substance_Name_Domain
      jurisdictionSubstance_Name.Jurisdiction
      synonymn/a
      translationn/a
      officialSubstance_Name.Official_Name
         authorityOfficial_Name.Official_Name_Type
         statusOfficial_Name.Official_Name_Status
         dateOfficial_Name.Official_Name_Status_Change_Date
      sourceSubstance_Name.Reference_Source
   relationshipSubstance.Reference_Information.Relationship
      substanceDefinition[x]Substance_Relationship.Related_Substance_Id
      typeSubstance_Relationship.Relationship_Type
      isDefiningSubstance_Relationship.Is_Defining
      amount[x]Substance_Relationship.Amount.Quantity
      ratioHighLimitAmountSubstance_Relationship.Amount.Quantity.High_Limit
      comparatorSubstance_Relationship.Amount_Type
      sourceSubstance_Relationship.Reference_Source
   nucleicAcid(used to add specifics of Nucleic Acids to Substances)
   polymer(used to add specifics of Polymers to Substances)
   protein(used to add specifics of Proteins to Substances)

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

RoutineSubstanceDefinition
SubstanceDefinitionEntity, Role, or Act
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   grade
      idn/a
      extensionn/a
      codingunion(., ./translation)
      text./originalText[mediaType/code="text/plain"]/data
   moiety
      idn/a
      extensionn/a
      modifierExtensionN/A
   characterization
      idn/a
      extensionn/a
      modifierExtensionN/A
   property
      idn/a
      extensionn/a
      modifierExtensionN/A
   molecularWeight
      idn/a
      extensionn/a
      modifierExtensionN/A
   structure
      idn/a
      extensionn/a
      modifierExtensionN/A
      representation
         idn/a
         extensionn/a
         modifierExtensionN/A
   code
      idn/a
      extensionn/a
      modifierExtensionN/A
      code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         coding (unii)union(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         coding (uniProt)union(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         text./originalText[mediaType/code="text/plain"]/data
   name
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
      official
         idn/a
         extensionn/a
         modifierExtensionN/A
   name (sub)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      official
         idn/a
         extensionn/a
         modifierExtensionN/A
   name (gsrs)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      official
         idn/a
         extensionn/a
         modifierExtensionN/A
   name (isbt)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      official
         idn/a
         extensionn/a
         modifierExtensionN/A
   relationship
      idn/a
      extensionn/a
      modifierExtensionN/A