EDQM conducts inspection programme in China
This article was originally published in SRA
The European Directorate for the Quality of Medicines & Healthcare has carried out an inspection campaign at sites in China manufacturing active substances for pharmaceutical use1.
The campaign was part of the EDQM’s regular inspection programme for sites covered either by a certificate of suitability for compliance with European Pharmacopoeia monographs or an application for the same. It brings to over 180 the total number of sites inspected under the programme, most of which are in Asia.
The EDQM notes that China’s pharmaceutical industry has undergone considerable transformation over the last few years and should continue to grow, “with China becoming one of the world’s foremost markets”. “It is therefore very important for the EDQM to set up and maintain communications with the Chinese pharmaceutical industry and also to provide training sessions on a regular basis so that they can work together to ensure that production quality requirements are met in order to protect public health.” There are plans to repeat the campaign in 2010.
Separately, the EDQM has decided to exclude from the scope of its certification procedure products classified as “other biological substances” by the European Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralised Procedures2.
The decision was taken in light of discussions held at the European level on the definition of biological products, the EDQM said. The certification procedure is intended for substances for which a monograph has been adopted by the European Pharmacopoeia Commission.
The characterisation and determination of biologicals, the EDQM noted, “require not only a combination of physico-chemical and biological testing, but also extensive knowledge of the production process and its control”. The decision applies only to new applications for certification.
References
1. EDQM press release, 2 November 2009, www.edqm.eu/medias/fichiers/EDQM_and_China.pdf
2. EDQM announcement, 22 October 2009, www.edqm.eu/en/News-General-Information-164.html