Adrian Kirk

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) recently closed consultation on its draft guidance, ICH Q10 Pharmaceutical Quality System. If all goes to plan, adoption could come as soon as Spring 2008.

Anyone familiar with the USA v Barr Laboratories case of 1993 will recognize the importance of not ignoring OOS results, and the inappropriateness of testing into compliance.