CRED Getting the CMC Dossier Right 2024

28/08/2024

Due-Diligence Tips – full Module 3.2.S (and ASMFs)

• Have all manufacturing sites been listed (including milling sites)? Does the information on the GMP certificate match the eAF application form?

• Has the specification been appropriately justified?

• Are stability results within spec and has the correct spec been used. If not have there been changes in the spec which need to be explained? • Have non-pharmacopeial methods been appropriately validated?

• The QOS should be aligned to module 3.2.S.

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Learning Objectives

• Origin of the Common Technical Document

• Overview of CTD structure - where drug substance data fits (Module 3.2.S) • Different routes to incorporate drug substance data into 3.2.S: originator data, ASMF or CEP

• Overview of variations in the EU

Due-Diligence Tips

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