CRED Getting the CMC Dossier Right 2024

Certification of Substances Department

CSA/AK/ CB PUBLIC DOCUMENT (LEVEL 1) English only

PA/PH/CEP (04) 1, 7R

Strasbourg, March 2024

Certification of suitability to Monographs of the European Pharmacopoeia

CERTIFICATION POLICY DOCUMENT Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use

Implementation date

01 May 2024

Tel ► +33 (0) 3 88 41 30 30 Mail ► cep@edqm.eu

EDQM 7 allée Kastner, CS 30026, F-67081 Strasbourg