Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences)

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This Second Edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21^st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.

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