Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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

## Substance Characterisation (3.2.S.3)

Page standards status: Informative

### 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

- For a drug product containing more than one active drug substance, the CMC eCTD 32S3 Document should be provided in its entirety for each drug substance.
  - CMC eCTD 32S3 Document - profile on Bundle Resource (representing the FHIR XML content as a collection of content in a single “document” and which should be repeated for each active substance). There will be one document profile for each S section in module 3.
- The preferred formats for both the Impurity Structure Graphic and Analysis Graphic are .png and .svg.
- Guidance in how to prepare SD Files for ANDAs, NDAs, and BLAs is available here: Quick Guide to Creating a Structure-Data File (SD File) for Electronic Common Technical Document (eCTD) Submission. Guidance in how to prepare SD Files for DMFs is available here: Quick Guide to Creating a Structure-Data File (SD File) for DMF Submissions
  - The SD Files should be included in the 32S3 XML bundle as documented in the IG.

### Representation in FHIR

- Drug Substance
  - Drug Substance (DrugSubstanceCharacterisation) profile on SubstanceDefinition resource
- Impurity Substance
  - Drug Substance Impurity (ImpuritySubstance) profile on SubstanceDefinition resource
- Related Organizations
  - Basic Organization (CodedOrganization) profile on the Organization resource

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

### CTD 3.2.S.3 Profile Map

### Usage Patterns

Not presently defined. Content will be added in the future when FDA PQ/CMC FHIR IG starts supporting other scenarios, for example new dosage forms such as liquids, etc.

### 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. CharacterisationBundle