The in-progress revision is designed to allow for producers to use non-distillation technologies for the production of water for injection (WFI).
It will bring the European Pharmacopoeia more closely into line with monographs in the US and Japan. The revision comes after decades of debate in Europe about which technologies are appropriate for pharmaceutical water production.
Distillation has been the primary method for producing water used in injectable drugs for many years, which contrasts with other industries where reverse osmosis (RO) and ultrafiltration (UF) have been accepted methods for almost as long.
Revision
Initial calls for revision of the WFI monograph in the late 90s were rejected on the basis that there was a lack of evidence to support the efficacy of RO, particularly in relation to its ability to prevent microbial contamination.
In 2010 the European Directorate for the Quality of Medicines & HealthCare (EDQM) set out to see if more supportive data was available and found that firms using such membrane-based technologies were consistently able to meet specs detailed in the monograph.
The finding did not prompt a revision because – as the EDQM noted at the time – most firms using RO also used UF and ultraviolet or ozone treatments. In addition, most had access to high-quality feed water.
Subsequent discussion of the findings by regulators and the drug industry acknowledged that membrane-based tech manufacturers have advanced prompting the European Pharmacopoeia to recommend revision of the monograph.
Webinar for industry
From a drug industry perspective other factors also came into play according to the EDQM, which told us “It seems that the advantage of using non-distillation technologies for the production of water for pharmaceutical use is linked to cost savings and sustainability benefits.”
The Strasbourg-headquartered organisation added that “use of such production systems is considered to help build green economy.”
The EDQM is holding a free online webinar for drugmakers and other industry stakeholders to learn about the monograph revision and its implications for the production of injectable pharmaceuticals.
The organisation told us "we are organising this webinar to raise awareness about the revision process and to ask stakeholder to contribute, the idea behind is to be sure at the end of the process to have captured all issues."
Registration details are available here.