A pharmaceutical company intends to source an active substan…
A pharmaceutical company intends to source an active substance from a new API manufacturer. The active substance manufacturer provides a Certificate of Suitability (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Employees believe that:”Since the supplier has a CEP, no additional information on the active substance is required in Module 3.2.S of the CTD.” Which statement best reflects the meaning of a CEP?