In April 2017, the European Medicines Agency (EMA) issued a concept paper with the purpose of update and revise the Note for Guidance on Quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01). This guideline was originally adopted in May 2002 and came into operation on 1st June 2002.
Since 2002, discussions have been held for many years as to whether there is a need to include non-distillation technologies as a method for production of water for injections (WFI) and eventually, during its 154th Session, the Ph. Eur. Commission adopted a revision of the monograph for Water for Injections (0169) allowing the use of non-distillation technologies for WFI production (the revised monograph was published in the Ph. Eur. Supplement 9.1).
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