Saturday 12 December 2020

Guideline on the quality of water for pharmaceutical use


Controlling water quality in pharmaceutical facilities requires an assessment of chemical and microbial risks. Of foremost concern is water-for-injections (WFI). This grade of water can be prepared using either reverse osmosis or by distillation. Concerns with endotoxin risks in relation to reverse osmosis are central to a new European Medicines Agency guidance paper relating to pharmaceutical water production.


In a new article, Tim Sandle considers the key messages within the guidance and the important learning points in relation to contamination control.


The new guidance document is useful, especially in providing examples of different applications of pharmaceutical water and the appropriate quality standards. The guidance supports the requirements of the European Pharmacopoeia and EU Guidelines to GMP, as well as providing an indication of the types of areas likely to be examined during a European regulatory inspection.


Sandle, T. (2020) Guideline on the quality of water for pharmaceutical use, GMP Review, 19 (3): 14-17


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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