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An Overview of cGMP Policies for Quality Management

Abstract: The FDA (Food And Drug Administration) initiatives for re-evaluation of cGMP policies (Current Good Manufacturing Practice) announced in August 2002, applies to veterinary drugs and human drugs, including human biological drug products. The FDA initiatives "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" concern the regulation of pharmaceutical manufacturing and product quality with an aim to focus GMP enforcement on high-risk products. It also aims at encouraging the adoption of modern and innovative manufacturing technology, and to develop consistent and predictable agency policies towards ensuring drug quality and safety.