FDA: Don't Wait On 'Case For Quality'; 'Build Bridges' To Better-Than-Baseline Practices Now
This article was originally published in The Gray Sheet
Executive Summary
FDA device center official William MacFarland is encouraging manufacturers to discover paths to better product quality by going above and beyond baseline GMP requirements. In the meantime, CDRH is making progress in its "Case for Quality" "critical-to-quality" pilot program, including the creation of 13 new CTQ information documents drafted by the agency, the director of the Division of Manufacturing and Quality within CDRH’s compliance office said. PLUS: MacFarland gives an update on FDA's commodity-based program alignment efforts, including his take on whether FDA investigators will be up to the task when it comes to reorganizing into product-specific silos.
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