Validation of Active Pharmaceutical Ingredients

1st Edition

Ira R. Berry, Daniel Harpaz

CRC Press
Published December 31, 2001
Reference - 618 Pages
ISBN 9781574911190 - CAT# PH1198

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Summary

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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