EDQM adopts revised monograph for WFI allowing non-destillation techniques

Recommendation

08 October 2019
Vienna, Austria

Container-/Closure-Integrity Testing of Parenterals

In a press release, the European Pharmacopeia Commission has announced that the revised monograph on Water for Injection (WFI) had been adopted.

According to the revised monograph, it will be allowed in Europe in future to produce WFI with a purification method equivalent to distillation like e.g. reverse osmosis coupled with appropriate techniques. Moreover, the EDQM declares that a notice to the respective supervisory authorities will be required when a "non-distillation" technology is used for the production of WFI. Besides, the EDQM points out that it is not only a matter of equivalence of a specification but rather the robustness of the purification of WFI. Therefore, Annex 1, which is currently under revision, will also include requirements with regard to the production of WFI. The new Annex 1 will be available when the revised monograph becomes applicable.

With the modification of this monograph, harmonisation with the US Pharmacopeia and the Japanese Pharmacopeia goes one step further. In both countries, non-distillation technologies for the production of WFI are already allowed.

The revised monograph Water for Injections (169) will be published in Ph.Eur. Supplement 9.1 and apply as of April 2017. For further information please see the EDQM's press release.