European Pharmacopoeia Revises WFI Monograph

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The agency now allows production of water for injection by non-distillation technologies.

The European Pharmacopeia (Ph. Eur.) Commission adopted a revision of its water for injection (WFI) monograph, during the agency’s 154th session on March 15–16, 2016, to include production of WFI by a “purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques,” according to an agency

. Use of non-distillation technologies when producing WFI, however, will require notification to the supervisory authority before implementation. The revised monograph is more in line with the US Pharmacopeia Convention’s and the Japanese Pharmacopoeia’s WFI requirements.


According to the press release, “Any non-distillation technology for producing WFI should be equivalent in quality to that produced by distillation, where equivalence in quality does not simply mean compliance with a specification but also takes into account the robustness of the production method. This is why the ongoing general revision of Annex 1 ‘Manufacture of sterile medicinal products’ to the EU Good Manufacturing Practice (GMP) guidelines will include new guidance on production methods for WFI. In order to ensure the necessary guidance will be available at the time when the revised WFI monograph will come into force, a Q&A document is currently being finalized by the GMP/GMDP Inspectors Working Group of the European Medicines Agency.”

The Ph. Eur. Commission decided to revise the monograph based on consultations with stakeholders, the results of a survey conducted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) in March 2010, and the conclusions found at an EDQM expert workshop conducted in March 2011. The revised monograph, which will become effective in April 2017, will be published in the Ph. Eur. Supplement 9.1.