Validation of Active Pharmaceutical Ingredients, Second Edition
Validation of Active Pharmaceutical Ingredients, Second Edition Books
Product Description
Much has happened in the area of bulk pharmaceutical excellent manufacturing do (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. The second edition is fully revised, updated, and expanded to include new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. New language has been introduced and the ancient language has been better defined to improve the understanding of correlated concepts and principles. With this book, readers gain a working knowledge of the regulatory administer that will facilitate their organization’s compliance.
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