Guidance on quality of water for pharmaceutical use

Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use

Up to now, the production of Water for Injections (WFI) had been limited to distillation only. The revision of the monograph for Water for Injections (0169) allows for production of WFI by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques. This brings the Ph. Eur. more closely in line with the US Pharmacopeia and the Japanese Pharmacopoeia which allow for production of WFI by distillation or a purification process proven being equal or superior to distillation, and by distillation or reverse osmosis followed by ultrafiltration.

A new concept paper has been issued by the European Medicines Agency: “This concept paper addresses the need to 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 then, there have been ongoing discussions 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 will be published in the Ph. Eur. Supplement 9.1 and will become effective in April 2017).

For further details see: EMA



Posted by Dr. Tim Sandle