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

This article was originally published in The Gold Sheet

Executive Summary

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 FDA’s last major attempt to revise the cGMPs, an ill-fated 1996 proposal, is formally withdrawn, clearing the way to further conform U.S. cGMPs with emerging quality systems approaches.

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