CEP 2.0 Implementation and its impact on Quality and Layout of CEP

The “CEP 2.0” (the new name for the CEP of the future) is a “new-look” CEP. Its new look will offer greater transparency of the information conveyed to CEP users without increasing the regulatory burden.

CEP 2.0 History

The process to redesign CEPs started in late 2020 with a public consultation, followed by a second, more targeted one in 2022. Based on the feedback received during these discussions, the Certification Steering Committee decided on the future design of CEPs. This impacts CEP applicants, holders and users of CEPs.

CEP 2.0 Implementation

The implementation process of the revised Certificates of Suitability to the EU Pharmacopeia (CEP 2.0) is marking a new step, as announced by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

CEP 2.0 will majorly impact all users; therefore, a stepwise approach is a must for its implementation. As a part of the implementation of CEP 2.0, as of 1st June 2023, the changes to the content of CEP applications will be implemented, and the use of updated application forms will be mandatory. Using the EMA SPOR/OMS Organisation (Org) and Location (Loc) ID will become mandatory for all sites listed in the application form.

What will Change?

• Layout

With its new look,  CEP will become an electronic document with a digital signature. It will be downloadable as a pdf or printed by CEP holders to share with their customers for inclusion in Marketing Authorisation Applications (MAA). EDQM will deliver no paper copy.

Find below the table listing a few updates in CEP 2.0 Layout:

To smoothen the implementation of CEP 2.0, the Coexistence of “New look” CEP, “Old look” CEP and “Hybrid look,” CEP will remain for some time. This will ensure an appropriate balance between updating the existing CEPs to the “new look” CEP and the burden generated for the holders / the EDQM / the other users. Let’s have an overview of the layout and implementation of “New look” CEP, “Old look” CEP and “Hybrid look” CEP.

• Quality

Implementing CEP 2.0 will also impact the content of the CEP dossier and CEP assessment process.

• Content and assessment of the CEP dossier

Some changes will be introduced regarding the content of the CEP dossier and associated assessment as listed below:

• The CEP dossier (modules 2 and 3) will reflect the assessment performed and the approved specification.
• Only relevant information should be included in the CEP dossier; e.g. CEP dossier should contain only information corresponding to the quality claimed. It is optional to apply for a grade on the CEP. If an applicant does not apply for a specific grade, data relevant to the grade, i.e. micronisation, particle size, sterilisation, etc., will not be assessed. The assessor will recommend removing such data from the dossier.
• In the CEP dossier section 3.2.S.1.3, it is requested include the Maximum Daily Dose (MDD), route of administration and treatment duration considered for developing the control strategy and specification presented in the CEP dossier.
• In the CEP dossier Section 3.2.S.2.3, it is required to specify the water quality used within the manufacturing process.
• CEP dossier Section 3.2.S.4.1 requires the specification in tabular format with parameters, limits and method reference (e.g. Ph. Eur., in-house).
• In the CEP dossier, Section 3.2.S.4.2 it is prompted not to reproduce details of the methods of the Ph. Eur. monograph; instead, it is asked to list out alternative analytical test procedures to those of the Ph. Eur. Monograph as subsection one and additional in-house method as subsection 2.
• EDQM policy on stability is changed, and they will now request CEP holders to propose a re-test period. It is not mandatory to propose a re-test period; however, the applicants will be encouraged to claim a re-test period and to include relevant stability data in their CEP applications.
• More flexibility in terms of storage conditions will be offered. Stability data regarding additional climatic zones (III and IV) and the corresponding re-test period will be assessed if the applicant proposes and includes it in the CEPs. Thus, the CEP holder is responsible for deciding their API’s storage and temperature conditions; however, the applicant must prove the proposed storage condition’s suitability.
• CEP applicants will have to provide a commitment to share information with their customers as part of the application form for a CEP. During GMP Inspection, EDQM will check the transparent sharing of information to CEP users/customers to enhance information sharing between the CEP holder and their customers.

• Changes to the online Public Certification database

The new features of the public CEP database would be:

• The EMA SPOR/OMS ORG_ID and LOC_ID are mentioned for the CEP holder.
• The availability of the history of the finalised procedures for each CEP application, i.e. the type of procedure, the end/finalisation date, the outcome (i.e. CEP revised, CEP remains valid etc.) and the corresponding CEP number, if.

Conclusion

With the new look, “CEP 2.0” will bring greater transparency within the information shared. It will widen the regulatory acceptance of CEPs through proposed changes in the content and assessment of CEPs.

For CEP applicants and CEP holders, it is important to understand proposed changes in the layout and quality of CEP and to implement them via required changes in their submissions. To ensure that their applications are processed smoothly, applicants have to meet the new expectations regarding CEP dossiers.

During the transition period, applicants/ CEP holders face challenges getting the right information and correctly strategising their submissions. In such a situation, one can contact PLG to get solutions to challenges faced during the implementation of CEP 2.0. PLG can help evaluate the impact of CEP 2.0 implementation on currently approved CEPs and new CEP applications. Our services can support getting approval for your CEP in line with CEP 2.0 with a new look and assessment. PLG experts know how to facilitate the creation of SPOR/OMS LOC/ORG ID/LOCATION ID. Our experts ensure end-to-end support for CEP procedures (new applications, revisions, renewals), such as preparation and review of CEP dossiers, regulatory submission, publishing and post-approval management.

Contact us to find out how PLG can provide tailored support to help you implement CEP 2.0.