Reverse osmosis as a means of water for injection production: a response to the position of the European Medicines Agency.

The purpose of this writing is to formalize a reply to the European Medicines Agency (EMEA) regarding their rejection of reverse osmosis (RO) as a suitable method for the generation of water for injection (WFI). As stated in EMEA/CHMP/CVMP/QWP/28271/2008, the EMEA preference is for distillation. The