Validation of Active Pharmaceutical Ingredients

Validation of Active Pharmaceutical Ingredients
Author :
Publisher :
Total Pages : 594
Release :
ISBN-10 : 0367801205
ISBN-13 : 9780367801205
Rating : 4/5 (205 Downloads)

Book Synopsis Validation of Active Pharmaceutical Ingredients by : Ira R. Berry

Download or read book Validation of Active Pharmaceutical Ingredients written by Ira R. Berry and published by . This book was released on 2001 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


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