Tuesday, 21 November 2017

Q&A production of water for injections by non-distillation methods



Q&A production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies – a new document of interest from the European Medicines Agency.

The document states: “Production of water for injection by other methods than distillation has been allowed in the EU since April 1st 2017. A draft additional guidance was published in 2016 and a Final Version of this document provides a set of questions and answers (Q&A) which are intended to provide preliminary guidance until such time the on-going revision of Annex I of the GMP guide is complete.”

For further details see: EMA


Posted by Dr. Tim Sandle

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