Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2 United States of America flag

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 1.1.2 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

Product Characterisation of Impurities (3.2.P.5.5)

Bundle Overview

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  • DRAFT PROFILE - NOT PART OF BALLOT
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Characterisation includes both Information on the characterisation of impurities . Reference ICH guidances Q3B, Q5C, Q6A, and Q6B.

eCTD Heading 3.2.P.5.5 Profile Map

eCTD Heading 3.2.P.5.5 Characterisation of Impurities BundleEctdComposition32P55Base64DocumentReferenceSponsorOrganizationDrugProductwithImpuritiesImpuritySubstanceBundle Reference:StructureDefinition-cmc-ectd-document-32p55.htmlParent:CompositionReference:StructureDefinition-ectd-composition-32p55.htmlValueSets:Code system PQCMC Comp Section TypesParent:DocumentReferenceReference:StructureDefinition-cmc-document-reference.htmlParent:OrganizationReference:StructureDefinition-cmc-sponsor-organization.htmlValueSets:Testing Site and Organization Identifier Type TerminologyParent:MedicationDefinitionReference:StructureDefinition-pqcmc-drug-product-with-impurities.htmlValueSets:Name Part TerminologyParent:SubstanceDefinitionReference:StructureDefinition-pqcmc-drug-product-substance-impurity.htmlValueSets:Impurity Classification TerminologyChemical Structure Data File Type Terminology

Example 3.2.P.5.5 Bundle