IPEC e-newsletter - Excipients Insight March 2017 - 31-03-17

 

Inside this issue

     

EMA considers revision of pharmaceutical water quality note of guidance

The European Medicines Agency (EMA) has published a concept paper that addresses the need to update and revise the Note for Guidance on Quality of water for pharmaceutical use, which came into operation in 2002.

There have been ongoing discussions for many years as to whether there is a need to include non-distillation technologies as a method for production of water for injections (WFI), and a revised European Pharmacopoeia (Ph. Eur.) WFI monograph which incorporated this method has been adopted and comes into effect in April, bringing the European requirements into alignment with the US and Japan.

The changes to the monograph (0169) will allow WFI to be produced by techniques other than distillation, including reverse osmosis which is an acceptable methods in the US and Japanese pharmacopeia monographs.

The current guideline needs to be updated to reflect imminent changes in Ph. Eur., says the concept paper. "Consequently, the opportunity will be taken to review current requirements to ensure that they are still appropriate and, if necessary, to amend."

The public consultation period on the document opened on 6 March and will conclude on 6 June.

 

 

 

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