How to read a CEP – European Directorate for the Quality of Medicines(EDQM)
Overview:- Aim and scope of EDQM policy document PA/PH/CEP(15)31 “How to read a CEP”
- How to interpret the information laid down on CEPs
- Highlight of the most important changes following the implementation of “CEP2.0”
- EDQM policy document PA/PH/CEP (15) 31 “How to read a CEP”, 2025 revised in May to cover CEP 2.0 and hybrid CEP in addition to old ones: Link
- It does not contain new information or new instructions, but it describes in detail the information conveyed on a CEP and clarifies how this information should be interpreted by both industry and competent authorities.
- It should be read in conjunction with other applicable EDQM Certification policy documents and guidelines.
- It does not cover the use of a CEP in the context of a Marketing Authorisation Application (MAA), where a CEP is used to replace the quality part of the CTD dossier related to that given source of the substance, or in any variation. Q&A How to use a CEP in the MAA and MAV © EDQM 2025 : Link
What is a CEP?
A chemical or a herbal CEP certifies that the quality of the substance is suitably controlled by the Ph. Eur. monograph and any supplementary tests deemed necessary in line with (V)ICH and EMA guidelines.
A TSE CEP certifies that the substance complies with the Ph. Eur. General Chapter 5.2.8 on minimizing the TSE risk. It does not certify that the quality of the substance is suitably controlled by a specific Ph. Eur. Monograph.
- A CEP does not replace a certificate of analysis.
- A CEP does not replace the QP declaration.
- A CEP is not a GMP certificate.
Formats of CEPs (all types of CEP)
In September 2023, major changes were introduced to the CEP document, which resulted in 3 different formats: “CEP 2.0”, “hybrid CEP” and “old CEP” :
Reference: How to read a CEP webinar – European Directorate for the Quality of Medicines & HealthCare