Wednesday, 5 August 2020

Guideline on the quality of water for pharmaceutical use

The European Medicines Agency has produced the final version of its guideline ‘Guideline on the quality of water for pharmaceutical use’.

The guidance has been issued to provide a regulatory perspective on the production of Water for Injection (WFI) using methods other than distillation, as per the earlier revision in the European Pharmacopeia.

The issuing of the new guidance, in July 2020, follows an earlier draft (with the same title) which was published in 2018. The draft remained out for public comment until mi- May 2019. 

The purpose of the guidance is to set out the water quality requirements for specific pharmaceutical production process (human and veterinary medicinal products, and Advanced Therapy Medicinal Products).This relates to three different pharmaceutical water qualities: WFI, purified water and water for the production of extracts. The quality of mains (supply) water is outlines, although this is not considered to be water of pharmaceutical quality.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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