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unjour unlabo a Day, a Lab - 12 December 2017, Lyon

  • Theme : The new bulk injectable water monograph: regulatory and technological challenge
  • Charles River Laboratory Visit

 


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In 2017, and after so many years of discussion, a new monograph on EPPIV is published by the European Pharmacopoeia. But it seems that in order to implement this new monograph, the EMA has to publish a text on the proper use of membrane systems to produce the EPPIV.
This document should be included in Annex 1. It appears that the EMA is not convinced of the robustness and efficiency at 100% of the time of these EPPIV production membrane systems.

This day should allow us to discuss this new monograph on L'EPPIV.

A little history concerning the appearance of the new monograph on Water for Injectable Bulk Preparations (EPPIV):

1969: Introduction to the 1 edition of the European Pharmacopoeia of Purified Water (EP). It is produced by distillation, ion exchange or any other equivalent technology
1973: Introduction to the 1 edition of the European Pharmacopoeia for Injectable Preparations (EPPI). It is produced only by distillation
1976: USP accepted reverse osmosis as an alternative method to produce EPPI
1983: Appearance of the 2th edition of the European Pharmacopoeia 5th Addendum, EPPI is still produced by distillation, but the discussion is launched to produce EPPI by RO / RO
1999: Discussion between EDQM_EMEA and USP_FDA
2002: Appearance of Highly Purified Water (EHP) in the 4th edition of the European Pharmacopoeia. It is produced by membrane systems (RO / EDI / UF or RO / RO / UF)
2004: USP modifies EPPI monograph by eliminating text from membranes
2016: New EPPIV monograph authorizing membrane systems, PE 9