EDQM's Annual Report 2015: 18% of the sites inspected were not GMP-compliant

Recommendation

22/23 February 2024
Munich, Germany

API Regulatory Starting Materials
Definition, Manufacture, Assessment and handling post-approval Changes

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:

• In 2015, a total of 391 new applications for a CEP were submitted - which is a significant increase over the previous years. The number of requests for revision (almost 1,900) also considerably increased by 16%.
• 291 new CEPs and 1,565 revised CEPs were issued.
• 38 manufacturing sites were inspected together with representatives of European supervisory authorities (Joint Inspections) - most of them located in Asian countries.
• 18% of the facilities inspected were not GMP-compliant.
• Thanks to the exchange of information between the inspectorates from EU Member States, data concerning the GMP compliance of 42 sites could be obtained. Where necessary, actions with regard to existing or submitted CEPs have been taken.

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.