Quality of water for pharmaceutical use - Scientific guideline
Table of contents
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
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Guideline on the quality of water for pharmaceutical use (PDF/269.52 KB)
Adopted
First published: 20/07/2020
Legal effective date: 01/02/2021
EMA/CHMP/CVMP/QWP/496873/2018 -
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Overview of comments received on the draft 'Guideline on the quality of water for pharmaceutical use' (EMA/CHMP/CVMP/QWP/496873/2018) (PDF/204.33 KB)
First published: 20/07/2020
EMA/CHMP/CVMP/QWP/230700/2020 -
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Draft guideline on the quality of water for pharmaceutical use (PDF/133.54 KB)
Draft: consultation closed
First published: 15/11/2018
Consultation dates: 15/11/2018 to 15/05/2019
EMA/CHMP/CVMP/QWP/496873/2018 -
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Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V) (PDF/84.01 KB)
Draft: consultation closed
First published: 06/03/2017
Last updated: 06/03/2017
Consultation dates: 06/03/2017 to 06/06/2017
EMA/CHMP/CVMP/QWP/BWP/428135/2016 -
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CPMP position statement on the quality of water used in the production of vaccines for parenteral use (PDF/104.54 KB)
Adopted
First published: 20/10/2003
Last updated: 20/10/2003
EMEA/CPMP/BWP/1571/02/ Rev 1 -
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Note for guidance on quality of water for pharmaceutical use (PDF/136.64 KB)
Adopted
First published: 01/05/2002
Last updated: 01/05/2002
Legal effective date: 01/06/2002
CPMP/QWP/158/01 Revision