EDQM adopts revised monograph for WFI allowing non-destillation techniques

In a press release the EDQM has announced that the new monograph draft on Water for Injection (169) had been adopted. Read on to learn more about the production of WFI with membrane systems.

http://www.gmp-compliance.org/enews_05274_EDQM-adopts-revised-monograph-for-WFI-allowing-non-destillation-techniques_15254,15160,15090,15267,Z-PEM_n.html

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…