Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success

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Edition: 2

Series: Drugs and the Pharmaceutical Sciences

ISBN: 9780849391842, 0849391849

Size: 4 MB (3902611 bytes)

Pages: 306/306

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D. Hynes III Martin9780849391842, 0849391849

This Second Edition is an essential guide to preparing for inspections-taking into account current trends in FDA expectations and enforcement activities, such as quality systems-based approach to inspections, risk-based inspections, and the GMPs of the 21st century to produce rapid regulatory approval.

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