EU Certificate of Suitability (CEP) Explained: Ultimate Guide to EDQM Filing, Renewal, and Compliance EU Certificate of Suitability (CEP): Compliance-Driven Guide for API Regulatory Affairs Professionals Introduction to CEP and Its Importance The Certificate of Suitability (CEP), issued by the European Directorate for the Quality of Medicines & Healthcare (EDQM), certifies that an Active Pharmaceutical Ingredient (API) complies with the monograph of the European Pharmacopoeia (Ph. Eur.). The CEP allows API manufacturers to demonstrate quality and suitability for use in finished products without submitting full technical details to each national authority in the EU. By 2025, CEPs are strategic assets…