Introduction

The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. New methods that are equivalent to the distillation for water will be included in the guideline.

The guidance provided by the draft should also be considered for new marketing authorisations, variation applications to marketing authorisations as well as Advanced Therapy Medicinal Products.