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Modernized GMPs

Executive Summary

FDA's Manufacturing Subcommittee of its Pharmaceutical Science Advisory Committee will discuss modernized good manufacturing practices for process validation on April 18-19. The subcommittee will also receive updates on International Conference on Harmonization quality guidelines Q8, Q9 and Q10 plus future ICH quality topics. The subcommittee will also discuss FDA's CMC Pilot Program and guidance. The meeting will be held at CDER's advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8:30 a.m. on both days...

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