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U.S.A. GMPs: What Offshore API Manufacturers Need to Know
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This 341-page PDF outlines a course that Mr. Buhay gave in Beijing last year, summarizing what any manufacturer outside the U.S. should know about GMPs and FDA regulations.
Author: Nicholas Buhay, Deputy Director of Manufacturing and Product Quality, FDA's CDER | File Size: 4.31 MB | File Type: PDF
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