Module 3 Presentations

14/05/2024

API MANUFACTURE AND IN-PROCESS CONTROLS: Section 3.2.S.2 Dr Mike James Cambridge Regulatory Services mikejames@cambreg.co.uk

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Learning Objectives

 What to put in the subsections of 3.2.S.2 Manufacture of Drug Substance  Considerations for choice of Regulatory Starting Materials  Critical Quality Attributes and Control of Process Description  Changes to synthetic route and need to relate them to commercial route in 3.2.S.2.2

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