Friday, 19 May 2017

European Pharmacopoeia 9th Edition (Supplement 9.1)

The 1st supplement 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