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

eCTD Substance Characterisation (3.2.S.3)"

Bundle Overview

This bundle contians information for these section headers: 3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) and 3.2.S.3.2 Impurities (name, manufacturer) NCE: Confirmation of structure based on e.g., synthetic route and spectral analyses should be provided. Information such as the potential for isomerism, the identification of stereochemistry, or the potential for forming polymorphs should also be included. Reference ICH Guideline: Q6A Biotech: For desired product and product-related substances, details should be provided on primary, secondary and higher-order structure, post-translational forms (e.g., glycoforms), biological activity, purity, and immunochemical properties, when relevant. Reference ICH Guideline: Q6B

Information on impurities should be provided. Reference ICH Guidelines: Q3A, Q3C, Q5C, Q6A, and Q6B

eCTD Heading 3.2.S.3 Profile Map

Example 3.2.S.3 Bundle