Quality of water for pharmaceutical use - Scientific guideline

This guideline applies to human and veterinary medicines.

July 2020 update: The guideline has been updated to reflect changes in the European Pharmacopoeia including the revised monograph for Water for Injections allowing methods other than distillation for producing water of injectable quality. 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 updated guideline will be effective from 1 February 2021.

Keywords: Water, pharmaceutical use, grade, excipient, water for injections, purified water, distillation, reconstitution

Current effective version

Guideline on the quality of water for pharmaceutical use

AdoptedReference Number: EMA/CHMP/CVMP/QWP/496873/2018Legal effective date: 01/02/2021

Document history

Guideline on the quality of water for pharmaceutical use

AdoptedReference Number: EMA/CHMP/CVMP/QWP/496873/2018Legal effective date: 01/02/2021

Overview of comments received on the draft 'Guideline on the quality of water for pharmaceutical use' (EMA/CHMP/CVMP/QWP/496873/2018)

Reference Number: EMA/CHMP/CVMP/QWP/230700/2020

Draft guideline on the quality of water for pharmaceutical use

Draft: consultation closedConsultation dates: 15/11/2018 to 15/05/2019Reference Number: EMA/CHMP/CVMP/QWP/496873/2018

Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)

Draft: consultation closedConsultation dates: 06/03/2017 to 06/06/2017Reference Number: EMA/CHMP/CVMP/QWP/BWP/428135/2016Summary:

This concept paper addresses the need to update and revise the Note for Guidance on Quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01). This guideline was originally adopted in May 2002 and came into operation on 1st June 2002.

CPMP position statement on the quality of water used in the production of vaccines for parenteral use

AdoptedReference Number: EMEA/CPMP/BWP/1571/02/ Rev 1

Note for guidance on quality of water for pharmaceutical use

AdoptedReference Number: CPMP/QWP/158/01 RevisionLegal effective date: 01/06/2002

Superseded documents

Reflection paper on water for injection prepared by reverse osmosis

AdoptedReference Number: EMEA/CHMP/CVMP/QWP/28271/2008