News about GMP/cGMP


EMA: Draft Q&A on WFI Production by Non-Distillation Methods

The EMA has just published a draft for a questions and answers paper on production of water for injections (WFI) by non-distillation methods. The Ph.Eur. monograph for WFI was revised to include, in addition to distillation, reverse osmosis (RO) coupled with suitable techniques, for the production of WFI.


The purpose of these Q&As is to provide clarification and guidance in relation to the use of reverse osmosis in the manufacture of WFI (Part I) and also to provide more detailed guidance on the control of Biofilms (Part II). It is intended to provide preliminary guidance until such time the ongoing revision of Annex I of the GMP guide is complete.

Issues discussed are:

  • Identification of supervisory authority
  • Main concerns around the use of reverse osmosis
  • Main elements in the design of a WFI system
  • Qualification of a WFI system
  • Sampling regime
  • Testing during initial qualification and routine operation sampling
  • Preventative maintenance on RO systems
  • Definition of bioflm
  • Control strategy in the context of biofilm and contamination control
  • Removal of biofilms


EMA: What's New? - Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies



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