CEP 2.0 completely new? Effects on the quality and layout of the certificate

8. December 2023

The high quality that we strive for in our portfolio is also reflected in our service. One aspect of this service is to make the usage of our excipients as simple and safe as possible; hence, we have selected products certified by the “European Directorate for the Quality of Medicines & HealthCare” (EDQM). The recent renewal of the certification system brings with it a number of improvements and changes.

The CEP (Certification of Suitability of Monographs of the European Pharmacopoeia) is a certificate introduced by the European Directorate for the Quality of Medicines (EDQM). It certifies that the quality of a substance is suitably controlled by the corresponding monograph of the European Pharmacopoeia and complies with current legal requirements.

In order to obtain a CEP certificate, a comprehensive dossier in eCTD (Electronic Common Technical Document) structure must be submitted to the EDQM. After an extensive review process, this certificate confirms that all requirements of the respective monograph and applicable pharmaceutical guidelines have been met. The use of the CEP certificate drastically reduces the regulatory documentation effort and the associated costs for our customers (more on this in our next newsletter).

The implementation process for the redesign of CEPs at the EDQM began at the end of 2020 and as from September 2023 only CEP 2.0 certificates are issued under the new certification system. This has an impact on the CEP application, CEP holder and CEP user.

CEP 2.0 – the changes:

Digital format

The CEP 2.0 is an electronic document with a digital signature. CEP holders can download it as a PDF document or print it out to provide it to their customers for their approval documents; there will no longer be a paper copy. With CEP 2.0, the status of certificates and changes will be available in real time, making the procedure more user-friendly.

Due to the omission of the “Declaration of Access Box” on the new CEP certificates, a “Letter of Access” will now be issued by the CEP holder.

Increased transparency

The scope of information in the CEP 2.0 certificate has been increased. For example, the specification, including the release-relevant analysis methods of the certified substance, are now also provided.

Reduced regulatory effort and reduced follow-up costs for our customers

Certificates are now only renewed in the event of significant changes to the product.

The new EDQM principle stipulates that a CEP certificate is only renewed if the content of the certificate is affected by the changes submitted. This significantly reduces the documentation effort on the customer side and the associated costs.

Validity of the certificates

As from September 2023, certificates will only be emitted in accordance with the new system. Nevertheless, the old certificates will remain valid. During the transition phase, “hybrid certificates” will also be issued; according to current knowledge, these are also permanently valid.

Overview of the changes

You can see all the differences between CEP, hybrid and CEP 2.0 in the clear graphic (open graphic)

Conclusion

Overall, the CEP 2.0 aims to improve user-friendliness and provide more detailed information. When our customers use a CEP in their registration documents, it also makes registration activities easier (saves time, reduces costs).

If you have any further questions about CEP 2.0, please feel free to contact us at any time.

If you are curious and interested in more detailed information and innovations in the course of the CEP 2.0 implementation, you can inform yourself in detail on the EDQM homepage. A further document with the most important changes in connection with the implementation of CEP 2.0 can be downloaded here as a PDF (source: EDQM – What is the CEP 2.0).

CONTACT

Silke Möschter

Dr. Silke Möschter is Chief Pharmacist at IOI Oleo GmbH. After obtaining her license to practise pharmacy and a subsequent doctorate in pharmaceutical chemistry, she gained experience in various business areas in several pharmaceutical companies −be it Analytical Chemistry, Pharmaceutical Development, Quality, Regulatory Affairs or Operational Excellence. This know-how enables her to work at interdisciplinary interfaces and apply her extensive experience in the pharmaceutical sector to her daily work. At IOI, she is enthusiastic about both the large number of friendly colleagues and the versatility of the exclusively plant-based products.