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Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing)

Publisher CRC Press
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Book Details
PublisherCRC Press
ISBN / ASIN1574445162
ISBN-139781574445169
Sales Rank2,260,347
MarketplaceUnited States 🇺🇸

Description

Written by experienced authorities in process validation, Process Validation in Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate various techniques and approaches in the validation of biopharmaceutical processes.

Provides specific examples of failure modes and effect analysis (FMEA) that help you establish this method in your organization