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FDA's New Quality System Guidance: Minimizing a Pharmaceutical Company's Risk

By 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.

The question of whether a company has complied with cGMPs is often at the center of a product liability lawsuit involving a drug product when an injury or safety concern arises. While the Guidance Document is not legally binding on either the FDA or on a company, it serves as the agency's current thinking,
and compliance with the FDA's recommendations may demonstrate adherence to best industry practice. At a minimum, drug companies should review the Guidance Document to evaluate how they can improve their overall quality system, which may reduce product liability exposure.

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