Overview of the Requirements on WFI in the EU, USA and Japan

Again and again, the question arises about the limits laid down in the different GMP regulations and Pharmacopoeias and what procedures are applicable to the manufacture of water for injection (WFI). The table below gives you an overview of the current requirements on the production as well as on certain testing elements. It is remarkable to notice that only EU authorities are against the inclusion of membrane procedures for the production of WFI.