22/23 February 2024
An important part of the CEP procedure by the EDQM is the inspection of the site where the APIs are being manufactured. The objective of such inspections is on the one hand to check whether the company produces according to the requirements laid down in the dossier which has first been submitted to the EDQM and, on the other hand to check whether the GMP rules are being fulfilled.
A section of EDQM's recently published "Annual Report 2015" is dedicated to this certification procedure. It contains some interesting facts and figures about CEPs issued and inspections performed. Please find below a short summary:
According to the EDQM, around 60% of the sites located in Asia holding one or more CEPs could be covered by the inspection programme.
Meanwhile, EDQM's certification department counts some hundred assessors from 24 different competent authorities in charge of assessing CEP applications. CEPs may cover the purity of chemically-synthesised APIs, herbal APIs, or the risk of TSE.
According to EDQM's annual report, there are currently more than 4,200 valid CEPs. This number highlights the significance of the certification procedure when the quality of an API has to be documented within the marketing authorisation application for a medicinal product.