The format of the new CEP

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:

• A lack of knowledge of current EDQM policies on the content of the CEP
• A lack of knowledge and understanding of duties of CEP holders/manufacturers and MAH/Drug Products manufacturers
• A lack of knowledge and understanding of current regulations and how to use CEPs
• Expectations for more information on CEPs to increase transparency and clarity for users
• A wish to extend assessments in CEP dossier (e.g. stability)
• Requests to reduce revisions of CEPs (e.g. administrative changes)
• Enhance use of public database/IT tools

As results from the consultation, 5 areas of improvements have been identified by EDQM:

Revision to the information to be reported on a CEP

• Clarifies the aspects approved or not approved on the CEP
• Fill in gaps with information reported on CEP

Reduction of CEP revision numbers and facilitation of changes handling

• Avoid revisions of CEPs linked to administrative changes,
• Avoid revisions of CEPs not impacting the quality of the substance covered

Digital tools and public databases enhancement

• Implement a digitally signed electronic CEP.
• Use IT tools to facilitate the preparation and use of CEPs
• Update EDQM databases to include more features and to disclose more information

Increased sharing of information between CEP holders and medicines manufacturers

• Disclose more information in the CEPs and in the online “certification database”.
• Identify ways to enforce and verify information sharing.

Training to users on content and use of CEPs

• Provide more training and use the full range of EDQM communication tools to explain what is covered by CEPs and how CEPs should be used.
• Enhance information and improve visibility on the EDQM website to facilitate easier access to all relevant data.

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.