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Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success

Обложка книги Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success

Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success

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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