Risk-Based GMPs: FDA Priorities Will Reflect Exposure, Compliance Record
This article was originally published in The Tan Sheet
Executive Summary
FDA's risk-based inspection model will consider a product's breadth of use when assigning inspection priorities
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Manufacturing Subcommittee of the Advisory Committee on Pharmaceutical Science, which was slated to meet March 21, will instead combine that agenda with next scheduled meeting May 21-22. Inaugural meeting of the subcommittee was cancelled due to war in Iraq; FDA was expected to outline its progress on the "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" initiative (1"The Tan Sheet" Sept. 2, 2002, p. 13)...
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