EMA Proposal Would Give Popular Alternative For Pharmaceutical Water A Foothold in Europe
Executive SummaryThe 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.
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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.
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