The European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). In the USA, cold production i.e. via membrane processes is also allowed. The discussion of whether to allow cold production of WFI in Europe too has been lasting. The EDQM wants to find out the current state-of-the-art through a survey among the stakeholders and consider a possible change in the European Pharmacopoeia. We have asked the GMP Newsletter's readers if such a change would be interesting for them.
Users of water systems and system suppliers were surveyed separately. Yet, the answers they gave are surprisingly very similar.
The possibility to produce WFI cold via membrane processes is equally interesting for both pharma users and system suppliers. However, more than 90% of the users believe that distillation is still the safest alternative. That's why over 50% of them first want to wait for the results from other pharmaceutical companies. More than 80% think that the international pharmacopeias should also be harmonised before. The harmonisation of the pharmacopoeial requirements is what the system suppliers want too. Most interesting: more than half of the surveyed suppliers don't believe that the alternative production of WFI via membrane processes would reduce the costs for the operators, contrary to what has been thought by the users.
Please also see the complete results.
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)