FDA Proposes to Ease Reporting Burden for Low-Risk CMC Changes
This article was originally published in The Gold Sheet
Executive Summary
FDA relaxes approach to 40 types of low-risk manufacturing changes.
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FDA officials say that drug manufacturers need to have better trending and monitoring programs in place to detect process drift in drug manufacture. They note that many of the controls needed to prevent process drift are already embodied in existing GMP regulations but are underutilized.