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13 March 2008

EMEA:
Reflection Paper on Water for Injection Prepared by Reverse Osmosis

This Reflection Paper has been developed jointly by the QWP and the GMDP Inspectors Working Group, and outlines why it is currently not considered acceptable to use reverse osmosis for the production of water for injections (WFI).

The paper aims to stimulate reaction from stakeholders, with the view of reopening the discussion on it if needed, in view of recent technological advancements in this field.

Comments on it, possibly supported by data, should b sent to qwp@emea.europa.eu