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Water for Injection (EDQM)
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 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.
Outcome:
Return the filled in survey and supportive data until May 30, 2010. Manufacturers are encouraged to channel their answers through the association they belong to.
Links:
EDQM/ Announcement
EMA/ Reflection Paper