| Validation of Active Pharmaceutical Ingredients Revised Edition Contributor(s): Berry, Ira R. (Editor), Harpaz, Daniel (Editor) |
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ISBN: 1574911198 ISBN-13: 9781574911190 Publisher: CRC Press OUR PRICE: $247.00 Product Type: Hardcover Published: December 2001 Annotation: 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. |
| Additional Information |
| BISAC Categories: - Medical | Pharmacology - Science | Chemistry - General |
| Dewey: 615.19 |
| LCCN: 00143894 |
| Physical Information: 1.37" H x 7.07" W x 10.35" (2.68 lbs) 618 pages |