Rule is First Step in FDA Effort to Rescue GMPs from the 1970s

POST-1970s DRUG CGMPs begin taking shape with FDA’s first revision in more than a decade. Gone are references to asbestos and certain pre-automation work processes. In are some new provisions that conform to current practices and that harmonize with other nations’ regulations. FDA’s last major attempt to revise the cGMPs, an ill-fated 1996 proposal, is formally withdrawn, clearing the way to further conform U.S. cGMPs with emerging quality systems approaches.