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Risk Management Programs for the Pharmaceutical Industry

April 2, 2019

The FDA’s cGMPs for the 21st Century: A Risk-Based Approach Initiative In early 2002, the Food and Drug Administration (FDA) announced their Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach initiative. According to the FDA position paper: “The FDA oversees the quality of drug products using a two-pronged approach involving review of information submitted in applications as well as inspection of manufacturing facilities for conformance to requirements for current Good Manufacturing Practice (cGMP). These two programs have served the country well by helping to ensure the quality of drug products available in the US. Now, as we approach the 25th anniversary of the last major revision to the drug cGMP regulations, it is time to step back and evaluate the currency of these programs.

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