Did you know?
Certification of Suitability to the monographs of the European Pharmacopoeia (CEPs) are widely used and recognised within the 39 countries adhering to the European Pharmacopoeia, but also in many other countries around the world, such as Australia, Canada, Morocco, New Zealand and Tunisia.
The granting of a CEP by the European Directorate for the Quality of Medicines (EDQM) does not imply that the CEP holder complies with GMP requirements, therefore Marketing Authorisation Holders are required to perform their duties when selecting active substance suppliers, but also through further regular audits. Indeed, a CEP only confirms the chemical purity of pharmaceutical substances to be used in pharmaceutical product in accordance with the corresponding monograph. It does not guarantee compliance of the supplier with GMP
EDQM has issued a public document clarifying CEP holders’ responsibilities towards their customers, to be kept in mind by Marketing Authorisation Holders when interacting with CEP holders.
The procedure for “Certification of Suitability to the monographs of the European Pharmacopoeia” (CEP) was created in 1994 (by the later known as the European Directorate for the Quality of Medicines – EDQM), to control the chemical purity of pharmaceutical substances to be used in pharmaceutical product.
Nearly three decades later, what were the main changes introduced in that process of certification and what will be the future of it?
First, the procedure has been extended in 1999 to substances with a risk of transmissible spongiform encephalopathy (TSE), which could be certified based on the European Pharmacopoeia Chapter 5.2.8 “Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products for human and veterinary use”.
Also in 1999, the EDQM launched a programme of inspection of manufacturing sites covered by an application for (a) Certificate(s) of suitability to the European Pharmacopoeia monographs
But since the beginning and until now, major regulatory and scientific developments impacted the pharmaceutical industry but also competent authorities; we can name the elemental impurities assessment, or the evaluation of the risk of nitrosamines presence, as well as globalisation and digital technology.
Therefore, the EDQM initiated a project to design the “CEP of the Future”.
Late 2020, EDQM gathered feedback from stakeholders through a wide public consultation on various aspects connected with the CEP, particularly its content, layout, format and use. Responses received were assessed allowing to design the CEP of the future, to be deployed by 2023.
Feedback received highlighted the following:
As results from the consultation, 5 areas of improvements have been identified by EDQM:
Revision to the information to be reported on a CEP
Reduction of CEP revision numbers and facilitation of changes handling
Digital tools and public databases enhancement
Increased sharing of information between CEP holders and medicines manufacturers
Training to users on content and use of CEPs
The design of the CEP of the future will be discussed with stakeholders and decision-making bodies during the second half of 2022, for a deployment by beginning of (May) 2023.
Would you like to know more about CEPs, the certification process or better understand advantages of active substance suppliers documented with CEPs for the management of your regulatory file?
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