March 2007
FDA’s New Quality System Guidance: Minimizing a Pharmaceutical Company’s RiskBy Alan Minsk and David Hoffman
On Sept. 29, 2006, the Food and Drug Administration (“FDA”) issued a final guidance on quality systems for pharmaceutical companies: formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product and service requirements, improve customer satisfaction, and ensure continual improvement. The “Quality Systems Approaches to Pharmaceutical Current Good Manu-facturing Practice Regulations” (the “Guidance Document”) is intended to help companies comply with the FDA’s current Good Manufacturing Practices (“cGMP”) regulations. The Guidance Document is part of the FDA’s Pharmaceutical cGMPs for the 21st Century Initiative, a program that seeks to integrate quality systems and risk management approaches into existing manufacturing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
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