Validation of Active Pharmaceutical Ingredients, Second...

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Validation of Active Pharmaceutical...

Validation of Active Pharmaceutical Ingredients, Second Edition

Name: Validation of Active Pharmaceutical Ingredients, Second Edition
ISBN: 9781574911190

Ira R. Berry, Daniel Harpaz

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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

카테고리:

Medicine - Pharmacology

년:

2001

판:

출판사:

CRC Press

언어:

english

페이지:

618

ISBN 10: