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EMA: Concept Paper on the Revision of Note on Quality of Water for Pharmaceutical Use

EMA: Concept Paper on the Revision of Note on Quality of Water for Pharmaceutical Use

Last week the EMA (European Medicines Agency) published a concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V) which addresses the need to update and revise the guidance which originally went into effect on 1st June 2002.


Following ongoing discussions for many years, whether a need exists to include non-distillation technologies as a method for production of water for injections (WFI) the Ph.Eur. Commission finally adopted a revision of the monograph for WFI that now allows the use of non-destillation technologies for WFI production. The revision of the monograph for Water for Injections allows for production of WFI by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques. This revision will become effective in April 2017 (as previously reported).

To reflect those changes, the Note for guidance on quality of water for pharmaceutical use (H+V) has to be updated accordingly to bring the documents in line. The EMA Quality Working Party has even recommended a consequent deletion of the monograph Water, highly purified (1927).

As stated by the EMA “the opportunity will be taken to generally review the content of the current guideline in terms of the specified minimum acceptable quality of water requirements, for different grades of water quality, in the manufacture of active pharmaceutical ingredients and medicinal products for human and veterinary use. However, considering the acknowledged possibility for risk based approaches to be applied as part of an overall control strategy to the control of bacterial endotoxins, particular consideration will be given to the specified minimum standard for quality of water used for the final processing steps of non-sterile drug substances used in sterile parenteral products."

What is the proposed timetable?

May 2017 – End of public consultation on the concept paper

October 2017 – Draft revision of the guideline released for public consultation.

In one of our next LOGFILES we will publish a detailed comment on the concept paper.


EMA: Scientific Guidlines


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