The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
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.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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Gebunden. Etat : 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. N° de réf. du vendeur 595074134
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