China - Here We Come

After a lengthy sales cycle Business & Decision Life Sciences have just closed our first compliance and validation deal in China - to retrospectively and prospectively validate a number of ERP systems for one of the largest state owned pharmaceutical companies in China.

The interesting part is that this is not only driven by a desire to export products to overseas markets such as the US (and not just APIs, but also finished pharmaceuticals), but this is also being driven in part by the Chinese State Food and Drug Administration (SFDA) looking to assure the safety of products in their own local market.

While it is understandable that commercial objectives drive the need to meet US and European regulatory expectations in the export market, the SFDA requiring the validation of computerized systems used in the distribution of pharmaceutical products appears to be a positive sign with respect to improving overall product quality and tackling the issues associated with counterfeiting and supply chain fraud which is a significant problem in China.

We'll be engaging with the client with a mix of local computer system validation experts from our Business & Decision office in Beijing as well as ERP validation experts from the U.K. and U.S. It certainly looks like a very interesting project from a number of perspectives and it will be interesting to see how seriously the Chinese government and local manufactures are taking cGMP and GDP.