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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Robert A. Nash, Alfred H. Wachter
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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Gebunden. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Robert A. Nash, Alfred H. WachterThe third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.Regulatory basis for process validatio. Seller Inventory # 595074134
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