Validation of Active Pharmaceutical Ingredients (Hardcover) (ISBN-13: 9781574911190)

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.

Author: Ira R. Berry
ISBN-10: 1574911198
ISBN-13: 9781574911190
Publisher: CRC Press
Language: English
Published: 12/31/2001
Pages: 618
Format: Hardcover
Weight: 2.68lbs
Size: 10.35h x 7.07w x 1.37d