EDQM says 18% of inspected API sites were non-compliant in 2015

By Phil Taylor

- Last updated on GMT

EDQM says 18% of inspected API sites were non-compliant in 2015

Related tags European pharmacopoeia Council of europe Edqm

Almost one in five active pharmaceutical ingredient (API) facilities inspected by the European Directorate for Quality of Medicines and Healthcare (EDQM) last year failed to meet quality standards.

The EDQM inspected 38 API manufacturing sites last year according to its annual report​ - mostly in Asia - with the help of national regulatory authorities. All told, 18% of sites were found to be non-compliant with Good Manufacturing Practice (GMP).

That represented an increase on the 12% non-compliance rate among 34 sites inspected in 2014, but remains well down on 2013 when 13 out of 34 sites failed to pass muster.

Information on GMP compliance of 42 other sites was also obtained by exchanging data with inspectorates from European Pharmacopoeia member states and international partners.

Inspection of sites is a fundamental part of the EDQM's oversight of APIs via the Certificate of Suitability (CEP) system, and is used to determine whether substances are being produced in accordance with the submitted product dossier and Good Manufacturing Practice.

A network of some 100 assessors and 30 national inspectors takes part in the evaluation of API quality dossiers and the inspection of manufacturing and/or distribution sites.

"The EDQM inspection programme is fully embedded in the certification system and it is estimated that about 60% of the sites located in Asia and linked to CEPs have been covered by this programme​," says the annual report.

During 2015, 391 new applications for CEPs were submitted - a 10% increase over prior years - and 291 new CEPs were approved by the EDQM.  Meanwhile, there were almost 1,900 requests for CEP revisions, up 16%.

The increase in applications reflects the "impact of globalization​" on the EDQM, said director Susanne Keitel, who said most of the new applications and requests for revision which originated outside Europe "came from India and China, reflecting the global trend for production of generic drugs​."

The efforts taken by the EDQM to expand international collaborations are part of "the beginning of a major evolution in the scope of our activities and the way in which we pursue them," commented Keitel.

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