NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Tuesday 9 September 2008

FDA revises cGMP guidelines

The FDA has amended its cGMP requirements for finished pharmaceuticals. This amendments concern aseptic processing, verification of performance of
operations by a second individual, and the use of asbestos filters. The FDA said it changes were to "modernise or clarify some of the requirements as well as to harmonize them with other FDA regulations and international cGMP standards". The amendments which are the first phase of an incremental approach to modifying the cGMP regulations will be effective from 8 December 2008.
FDA

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