The 1stsupplement to the 9th edition of the European Pharmacopeia became effective on 1st April 2017.
Of interest to readers:
Water for Injections (0169)
Production: revision to include purification processes equivalent to distillation (such as reverse osmosis coupled with appropriate techniques) for producing water for injections (WFI), in addition to distillation; use of non-distillation technologies for the Production of WFI requires that notice is given to the supervisory authority of the manufacturer before implementation.
A requirement for regular monitoring of total organic carbon has been added to further emphasize the specific test controls required in the Production section.
Posted by Dr. Tim Sandle