CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.2

EMA/CHMP/CVMP/QWP/850374/2015 Guideline on the sterilization of the medicinal product, active substance, excipient and primary container.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

19

3.2.P.3 Manufacture

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

20