Europe – 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. 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.

The European Pharmacopoeia (Ph. Eur.) provides quality standards for grades of water for
pharmaceutical use including Water for Injections (WFI), Purified Water and Water for preparation of extracts. Until April 2017, the production of Water for Injections (WFI) had been limited to production by distillation only. Following extensive consultation with stakeholders, the Ph. Eur. monograph for Water for Injections (0169) was revised in order to allow the production of WFI by a purification process equivalent to distillation, such as reverse osmosis coupled with appropriate techniques such as electrodeionisation, ultrafiltration or nanofiltration. The revised monograph was published in the Ph. Eur.
Supplement 9.1 and became effective on 1 April 2017.

This change brings the Ph. Eur. more closely in line with the US Pharmacopeia and the Japanese Pharmacopoeia, allowing production of WFI by distillation or by a purification process proven “equivalent or superior to distillation”, and “by distillation or by reverse osmosis and/or ultrafiltration”,respectively…