This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
Page standards status: Informative |
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 –
Note: Profile computable names (in parenthesis above) map to names in the Profile Map below.
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.
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