CEP: certificate of suitability to the European Pharmacopoeia

The CEP is issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe under the certification procedure established by Resolution AP-CSP (07) 1. It certifies that the quality of a substance produced by a named manufacturer by a defined process is suitably controlled by the relevant European Pharmacopoeia monograph, with any additional tests listed on the certificate itself, for example for impurities or residual solvents the monograph does not cover. There are chemical purity CEPs, TSE CEPs for materials with a risk of transmissible spongiform encephalopathy, and CEPs for herbal drugs and preparations. A CEP is recognised in all Member States of the Ph. Eur. Convention and in several other countries.

In a marketing authorisation dossier a CEP replaces most of Module 3.2.S: the applicant includes the certificate, the declaration of access from the CEP holder naming the applicant, and the parts of 3.2.S the certificate does not cover, typically the applicant's own specification, batch analyses and stability data for the substance. Because the assessment of the substance has been done by the EDQM, assessors do not reassess the manufacturing route, which shortens the quality review and avoids the need for an ASMF.

The EDQM maintains the certificate over its life. The holder must request a revision when the manufacturing process, the site or the specification changes, and the EDQM inspects CEP holders and can suspend or withdraw a certificate after a non-compliance finding, which it publishes. A revised CEP is reflected in the marketing authorisation through a variation, most often a Type IA under category B.III.1 of the classification guideline, while a suspended CEP means the substance from that manufacturer can no longer be used until the issue is resolved.

What goes wrong: an applicant files with a CEP whose declaration of access names a different company in the group; the certificate covers the monograph but not an impurity that the applicant's route of synthesis introduces, so the authority asks for additional data anyway; a revised CEP is received from the supplier and never translated into a variation; a suspension is published by the EDQM and noticed only when a batch is questioned; and a renewal is missed because the first CEP has a five-year validity and the one-time renewal is assumed to be automatic.