New pharmaceutical water quality guideline from February 2021

In 2018 the EMA had a public consultation (15th Nov 2018 – 15th May 2019) on draft guidance for industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products. This consultation has resulted in an update to the old 2002 guidelines and the new guideline will come into effect from February 2021. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf

Within the guideline, it is stated that the European Pharmacopoeia (Ph. Eur.) has set quality standards for three grades of water: water for injections (WFI), purified water and water for preparation of extracts. EMA also notes that potable water, while not covered by a pharmaceutical monograph, “is the prescribed source feed water for the production of pharmacopeial grade waters,” and must comply with the regulations on water intended for human consumption of a quality equivalent to that defined in Directive 98/83/EC or laid down by the competent authority.

The guideline itself provides recommendations for the minimum acceptable quality of water to be used for different uses and applications, including the manufacture of sterile and nonsterile medicinal products, active substances and water used for cleaning and rinsing equipment and container/closures for medicinal products.

The note for guidance has been updated to reflect the following changes in the European Pharmacopoeia:

  • revised monograph for Water for Injections (0169) allowing the possibility to use methods other than distillation for producing water of injectable quality (this change brings the Ph. Eur. more closely in line with the US Pharmacopeia and the Japanese Pharmacopoeia, allowing production of WFI by distillation or by a purification process proven “equivalent or superior to distillation”, and “by distillation or by reverse osmosis and/or ultrafiltration”, respectively);
  • new monograph for Water for preparation of extracts (2249);
  • suppression of the monograph for Water, highly purified (1927).

The guideline has also been updated to reflect current expectations for the minimum acceptable quality of water used in the manufacture of active substances and medicinal products for human and veterinary use.

The guideline can be read in conjunction with the questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies https://www.ema.europa.eu/en/documents/other/questions-answers-production-water-injections-non-distillation-methods-reverse-osmosis-biofilms_en.pdf and the comments received on the draft guideline https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-quality-water-pharmaceutical-use-ema/chmp/cvmp/qwp/496873/2018_en.pdf

Written by Emily Fletcher