EMA Heeds Calls To Relax Water Quality Threshold For Active Substance Fermentation Media
The European Medicines Agency’s first revision of its water quality guideline in 18 years has been updated to reflect current expectations for the minimum acceptable quality of water used in the manufacture of active drug substances and finished drug products.
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Drug companies have serious environmental- and affordability-related concerns over complying with stricter standards proposed by the European Medicines Agency regarding the quality of water used for manufacturing pharmaceuticals.
Recent guidance from a pharmaceutical industry group should help manufacturers in the EU make the transition from using highly purified water and steam distillation to other methods for preventing microbiological contamination of pharmaceuticals such as reverse osmosis. The guideline also addresses the cost of using membrane technology versus distillation technology.
The European Medicines Agency is inviting stakeholder feedback on a proposal to allow reverse osmosis as an alternative to steam distillation for making water for injections (WFI) for pharmaceutical manufacturing. EMA also would expand its water quality guideline to cover vaccines and advanced therapy medicinal products such as cell and gene therapies.