EMA releases new pharmaceutical water quality guideline

The EMA’s new guideline on pharmaceutical water quality provides recommendations for the minimum acceptable quality of water to be used for different uses and applications, including the manufacture of sterile and non-sterile medicinal products and active substances.

“Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resource to the development and maintenance of water purification systems.”

This guideline applies to the manufacture of active substances for both human and veterinary use, as well as advanced therapy medicinal products (ATMPs). It should be referred to for new marketing authorisation applications and variations to existing authorisations. The principles of this guideline may also apply to investigational medicinal product manufacture.

The guideline explains that the European Pharmacopoeia (Ph. Eur.) has set quality standards for three grades of water: water for injections, purified water and water for preparation of extracts. Potable water should be the source feed water for the production of pharmacopeial grade waters.

Recommendations are the provided for the minimum acceptable quality of water to be used for different uses and applications, including the manufacture of sterile and non-sterile medicinal products, active substances and water to be used for cleaning and rinsing equipment and container/closures for medicinal products.

Click here to view the full guideline.