New EMA pharmaceutical water quality guideline takes effect February 2021
The European Medicines Agency (EMA) on Monday issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021.The adoption of the guideline follows a public consultation that kicked off in November 2018, with EMA making mostly minor changes to the guideline aside from revisions to the table listing minimum acceptable quality of water for manufacturing active substances. (RELATED: Water quality for pharmaceutical use: EMA opens consultation, Regulatory Focus 15 November 2018).
“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,” EMA writes.
Within the guideline, EMA explains that the European Pharmacopoeia (Ph. Eur.) has set quality standards for three grades of water: water for injections (WFI), purified water and water for preparation of extracts. EMA also notes that potable water, while not covered by a pharmaceutical monograph, “is the prescribed source feed water for the production of pharmacopeial grade waters.”
The guideline itself provides recommendations for the minimum acceptable quality of water to be used for different uses and applications, including the manufacture of sterile and nonsterile medicinal products, active substances and water used for cleaning and rinsing equipment and container/closures for medicinal products.
EMA says the guideline applies to the manufacture of active substances for both human and veterinary, as well as to advanced therapy medicinal products (ATMPs), and should be consulted for new marketing authorization applications and variations to existing authorizations. “Where relevant, the principles of this guideline may also be applied to investigational medicinal products.”
The new guideline is also meant to be read in conjunction with EMA’s 2017 Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies document.