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Ph. Eur. to reconsider allowing Reverse Osmosis as manufacturing method for Water for Injection@Sun. 4 Apr. 2010


Dear Colleagues:

European Pharmacopoeia Commission

Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). Renewed discussions have taken place at the end of 2009 amongst regulators in Europe on the suitability of using Reverse Osmosis (RO) to produce WFI. Concerns from regulators regarding the use of RO for the production of WFI had previously been expressed in a reflection paper issued by the Joint CHMP/CVMP Quality Working Party in early 2008 (EMEA/CHMP/CVMP/QWP/28271/2008). It can be found on the European Medicines Agency (EMA) website.
(01/04/10) Further to these discussions and to determine whether or not the problems/issues listed in this reflection paper are still valid, the European Pharmacopoeia Commission during its 135th session requested the EDQM to follow-up this issue. To this end, the EDQM has initiated <http://www.edqm.eu/site/SurveyWaterForInjectiondoc-en-12376-2.html> a survey through industry associations to gather suitable information and data. The outcome of this survey and subsequent evaluation will further determine whether or not the monograph included in the European Pharmacopoeia dealing with WFI (Ph. Eur. 0169) should be amended to consider RO as a possible alternative. The list of points addressed in the survey is directly linked to those listed in the above mentioned reflection paper. Deadline to return the filled in survey and supportive data is 30 May 2010.
Manufacturers are encouraged to channel their answers through the association they belong to.

Even if you choose not to complete the survey (click on "a survey" above) or read the attachment, the questions posed are thought provoking.
With Best Regards,
Michael Anisfeld



Globepharm 313 Pine Street (Ste 204)

Deerfield IL 60015, USA

Ph: USA +1 847 914 0922

Fx: USA +1 847 914 0988

e-mail: consulting@globepharm.org







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