Abstract

Revision of the WFI monograph in the European Pharmacopoeia / All's well that ends well?!

After a rather drawn-out process, the European Directorate for the Quality of Medicines & HealthCare (EDQM) finally published a draft of their new monograph on Water for Injection (WFI) on their website "Pharmeuropa Online" in April 2015 [1]. This new draft explicitly includes membrane filtration as an additional, alternative production method for WFI, as opposed to the traditional method of distillation. According to current information, the new WFI monograph is expected to become legally valid as part of the European Pharmacopoeia (Ph. Eur.) by early 2017. This development constitutes a milestone in the history of pharmaceutical water treatment and is the most significant change since the introduction of sum parameters for electric conductivity and TOC in the USP 23 published in 1997. With this new revision, all major pharmacopoeias (Ph. Eur., USP, JP) will permit the production of WFI by reverse osmosis combined with additional processing methods. This allows a wide range of possibilities for the optimization of pharmaceutical water systems, with regard to both quality and economics. This article presents a review of this change process and looks ahead to possible future developments in WFI production using membrane filtration. Basis for the discussion are both the draft WFI USP monograph and an EDQM information paper Reverse Osmosis in Ph. Eur. Monograph Water for Injections (0169) of March 2015 which explains the position of the European regulatory authorities concerning this topic.

Korrespondenz:

Jochen Schmidt-Nawrot, Chemgineering Technology GmbH, Abteilungsleiter Energie & Infrastruktur, Kreuzberger Ring 13, 65205 Wiesbaden (Germany),
e-mail: jochen.schmidt-nawrot@chemgineering.com