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

Executive Summary

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.

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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.

Quality Regulatory Updates In Brief: EMA, FDA, EDQM And WHO

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EDQM surveys industry on RO for WFI

Should the European Pharmacopoeia let drug makers use reverse osmosis to produce water for injection? The European Directorate for the Quality of Medicines and Healthcare said April 1 that it is surveying industry on this question. EP requires distillation, while the U.S. Pharmacopeia allows reverse osmosis, although FDA imposes strict controls on it. The European Medicines Agency summarized the objections in a March 5, 2008, reflection paper: reverse osmosis cannot screen out contaminants smaller than water molecules, such as chlorine or volatile organic chemicals; and the reverse osmosis membrane can become, in effect, a bacterial fermenter by allowing a biofilm to form on its upstream side and possibly spread to the permeate side or secrete metabolic byproducts that could pass through the membrane. Reverse osmosis would be cheaper and more practical, and some say new technologies would make it safe. Responses are due May 30





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