The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a revised guideline “How to read a CEP”, describing in detail the information that Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) convey. This document is intended to clarify specific issues for industry and competent authorities, such as the meaning of statements figuring in all types of CEPs, but it also describes the three different CEP formats (CEP 2.0, Hybrid CEP and old CEP) resulting from the implementation of changes in the content of the CEP documents in September 2023.
Please read this document in conjunction with other applicable Certification policy documents and guidelines, available on the EDQM website at https://go.edqm.eu/CEPgl
See also:
“Certified for success” – Register now for the CEP conference
Validation of eCTD submissions for CEP applications
Save the date: Sterile substance CEP webinar on 4 June 2025
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