EMA Consultation: Draft guideline on the quality of water for pharmaceutical use

The European Medicines Agency has released for public consultation a draft guideline on the quality of water for pharmaceutical use.

Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials etc.

This document is intended to provide guidance to the industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use and should be considered for new marketing authorisation applications, as well as any relevant variation application to existing marketing authorisations.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to QWP@ema.europa.eu by 15 May 2019.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).