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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

Paper Addresses Non-distillation WFI

Apr 26, 2017, 15:26 PM
News Source Link:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/03/WC500222390.pdf?utm_source=echo4.bluehornet&utm_medium=Email&utm_campaign=Connector_3.22.17
RegulatoryNewsDate:
Apr 26, 2017, 15:08 PM

In March, EMA released a concept paper outlining plans to revise the Agency’s guidance covering the quality of water used for pharmaceutical purposes. The revision takes into account the recent decision by the European Pharmacopoeia to accept non-distillation water technologies to produce water for injections (WFI).

Comments are due June 6.

regulatory-news-regions:
  • Europe