Wednesday 16 September 2020

EMA Guideline on the quality of water for pharmaceutical use

The EMA Guideline on the quality of water for pharmaceutical use

EMA/CHMP/CVMP/QWP/496873/2018 adopted by CVMP for publication on 18 June 2020; it will be effective 010 February 2021

This guideline replaces the Note for guidance on quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01) and CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use (EMEA/CPMP/BWP/1571/02 Rev.1).

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

• revised monograph for Water for Injections allowing the possibility to use methods other than distillation for producing water of injectable quality;

• new monograph for Water for preparation of Herbal drug extracts

• suppression of the monograph for Water, highly purified

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.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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