Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 1.1.6 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

eCTD Substance Characterisation (3.2.S.3)

Domain Overview

The Substance Characterisation bundle profile provides a mechanism for the industry to submit Module 3 CTD 3.2.S.3 folder content to the FDA. This is a higher level CTD folder. At present this folder’s scope is the drug substance 3.2.S.3.1 – Elucidation of Structure and Other Characteristics and 3.2.S.3.2 – Impurities. Some of the content of these sections are described below –

  • 3.2.S.3.1 - Elucidation of Structure and Other Characteristics
    • Pictorial representations of the drug substance produced as the result of elucidating the structure or characterization of the drug substance through various techniques, including, but not limited to, NMR and mass spectrometry.
  • 3.2.S.3.2 – Impurities
    • For each impurity found within the drug substance, in addition to identifying the impurity by name, and UNII if known, the content includes pictorial representations of the impurities produced as the result of elucidating the structure or characterization of the impurity through various techniques, including, but not limited to, NMR and mass spectrometry.

Implementer Instructions

Representation in FHIR

Note: profile computable names (in parenthesis above) map to names in the Profile Map below.

CTD 3.2.S.3 Profile Map

<?xml version="1.0" encoding="us-ascii" standalone="no"?>3.2.S.3 eCTD Heading Characterisation BundleEctdComposition32S3CodedOrganizationDrugSubstanceCharacterisationImpuritySubstanceGraphicReferenceStructureReferenceBundle Reference:StructureDefinition-cmc-ectd-document-32s3.htmlParent:CompositionReference:StructureDefinition-ectd-composition-32s3.htmlValueSets:Code system PQCMC Comp Section TypesParent:OrganizationReference:StructureDefinition-cmc-organization.htmlParent:SubstanceDefintionReference:StructureDefinition-pqcmc-drug-substance-characterisation.htmlValueSets:Chemical Structure Data File Type TerminologySubstance ClassificationParent:SubstanceDefinitionReference:StructureDefinition-pqcmc-drug-product-substance-impurity.htmlValueSets:Impurity Classification TerminologyParent:Base64DocumentReferenceReference:StructureDefinition-pqcmc-graphic-reference.htmlParent:Base64DocumentReferenceReference:StructureDefinition-pqcmc-structure-reference.html

Usage Patterns

Not Applicable

Examples

This example demonstrates the characterization and impurities of ethylacetate. This image displays the narrative as inserted in the composition text element generated by the narrative transform. The XML can be found on the Artifacts page. The XML file with the publisher narrative is on the artifacts page and in the Bundle profile. 32532fe8-1bfb-4a0a-998d-9294742a9519