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Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences) - Hardcover

Book 8 of 80: Drugs and the Pharmaceutical Sciences
 
9780824708382: Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences)

Synopsis

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

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About the Author

Robert A. Nash, Alfred H. Wachter

From the Back Cover

Pharmaceutical Process Validation, Third Edition explores the roots of pharmaceutical process validation originating in Switzerland and Germany in the 1980s. It covers troubleshooting procedures, validation in contract manufacturing, and harmonization trends. New chapters include Validation for Medical Devices, Validation of Biotechnology Processes, Transdermal Process Validation, Integrated Packaging Validation, Statistical Methods for Uniformity and Dissolution Testing, Change Control and SUPAC, Validation in Contract Manufacturing, and Harmonization, GMPs, and Validation. It includes contributions by research and industry specialists from the U.S., Europe, and Japan.

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