Quality of water for pharmaceutical use
This guideline applies to human and veterinary medicines.
|Keywords||Water, pharmaceutical use, grade, excipient, water for injections, purified water, distillation, reconstitution|
This document is intended to provide guidance on the pharmaceutical use of different grades of water in the manufacture of active pharmaceutical ingredients and medicinal products.
This document is currently under review, see below.
Draft guideline on the quality of water for pharmaceutical use (PDF/133.54 KB)Draft: consultation open
First published: 15/11/2018
Consultation dates: 15/11/2018 to 15/05/2019
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
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
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