CRED Getting the CMC Dossier Right 2024

28/08/2024

Module 3.2.S Drug Substance

Section Title

Functional Area

3.1

Table of Contents

3.2

Body of Data

3.2.S

Drug Substance

3.2.S.1 General Information

Chemistry

3.2.S.2 Manufacture

Manufacturing

3.2.S.3 Characterisation

Chemistry

3.2.S.4 Control of Drug Substance

Control

3.2.S.5 Reference Standards

Control

3.2.S.6 Container Closure System Manufacturing

3.2.S.7 Stability

Control

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General points on content

• Neither the type nor extent of specific supporting data is addressed in ICH M4 – both may depend on regional guidance (“For example” used)

• Harmonised Content is not available for all sections – cross referenced to existing ICH guidelines where they exist. If not, check regional (EU/US).

• Section 3.2.R (Regional Information) provides examples of where content is not harmonised (e.g. Executed Batch Records – US only)

• When more than one drug substance used in a product – generally present one complete drug substance section followed by another – but- • Separate sections warranted when single drug substance made at two different manufacturing sites • Multiple references proposed within CTD – Q for Polymorphism, Particle size and Impurities

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