CEP stands for Certification of suitability to the monographs of the European Pharmacopoeia although COS (Certificate of Suitability) has the same meaning.
Aim of CEP
A CEP covering chemical purity and microbiological quality certifies based on the specific data supplied by the manufacturer, that the quality of a substance can be suitably controlled by the Ph. Eur. monograph the quality of a substance corresponds to the quality defined in the Ph. Eur. monograph
Types of CEP
There are several types of CEP -
1. Certificate for chemical purity and microbiological quality (Chemical CEP)
2. Certificate for herbal drugs and herbal drug preparations (Herbal CEP)
3. TSE Certificate (TSE CEP)
Revision of CEP
Revision of CEP means that the changes made to an application are reviewed to ensure compliance with current requirements of the procedure. The holder of CEP shall inform the EDQM of any change to information in the CEP application by sending an appropriate request for revision.
CEPs are revised in the following cases:
1. Any notification/minor revisions impacting the content of the CEP
2. Any major revisions even if the content of the CEP is not impacted or etc
Renewal of CEP
Renewal of a CEP means that an application is reviewed to ensure compliance with current requirements of the procedure.
The renewal occurs 5 years after the date of issue of the original certificate, regardless of the number of revisions which may have occurred in the interim period
CEP Suspension
Any statement of GMP non-compliance that is related to a manufacturing site covered by a CEP application initiates the decision making process on the validity of the CEPs concerned by the EDQM, regardless of whether the EDQM has been involved in the inspection or not.A decision is taken for all relevant CEPs and CEP applications.
What is the CEP 2.0?
The CEP 2.0 (new name of the CEP of the future) is a “new-look” CEP that will better meet the current needs of stakeholders and offer both enhanced user-friendliness and greater transparency of the information conveyed without, however, increasing the regulatory burden related to revisions of CEPs.
CEP 2.0: what will change?
In the context of the project of the CEP of the future, the EDQM organised in late 2020 a wide public consultation with its stakeholders.
This was followed in 2022 by targeted consultations in order to define the design of the CEP and discuss specific questions.
Based on the feedback received during these discussions the Certification Steering Committee decided on the future design of CEPs for which the deployment is expected for 2023. This will have impacts on CEP applicants, CEP holders and users of CEPs.
The changes linked to its implementation cover the following 9 areas and will be further detailed within the next months.
• Area 1: CEPs and information reported
• Area 2: Changes regarding assessment of CEP applications
• Area 3: On-line public certification database
• Area 4: Authorities database
• Area 5: Fostering information sharing between CEP holders & MAH
• Area 6: Reduction of revisions of CEPs
• Area 7: Impact of changes and their implementation
• Area 8: Trainings for CEP holders and CEP users
• Area 9: Revising documents available on the EDQM website
Resource Person:
- Prasadhi Shiva
- Barbara Pirola
