1 August 2017

EMA/INS/GMP/443117/2017
GMP/GDP Inspectors Working Group

Questions and answers on production of water for

injections by non-distillation methods reverse osmosis
and biofilms and control strategies
Final

Adopted by GMP/GDP IWG May 2016

Start of public consultation 5 August 2016

End of consultation (deadline for comments) 4 November 2016

This set of questions and answers is intended to provide preliminary guidance until such time the on-
going revision of Annex I of the GMP guide is complete.

Keywords Water for Injections, reverse osmosis, Biofilms, Control Strategies

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European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.