CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.4 Control of Excipients

● The specification, analytical procedures with validations for non-compendial excipients ● Functionality related characteristics – the omission vs inclusion should be discussed, if included in the relevant Ph. Eur. Monograph

● Novel excipients: full information in Module 3.2.S, including synthesis, discussion on impurities and toxicological data.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

25

3.2.P.5 Control of Drug Product

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

26