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Question of the Week

What is a CEP?

CEP stands for Certificate of Suitability to the Monographs of the European Pharmacopoeia of the European Directorate for the Quality of Medicines and Healthcare (EDQM). An applicant (usually the active substance manufacturer or wholesale dealer) can request this certificate from the EDQM. It serves as proof that a(n) (active) substance manufactured in accordance with the production process submitted by the manufacturer can be properly tested and inspected for quality in monographic tests to determine the content and impurities contained in the substance.
Unlike the EDMF/ASMF, a CEP can be requested not only for any type of active substance such as:
  • Organic active substances
  • Inorganic active substances
  • Herbal active substances
  • Active substances obtained through fermentation or bio-technology
    but also for excipients.
[GMP MANUAL, Chapter 21.C.3]

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