Description
This book provides guidelines and recommendations for the validation of biopharmaceutical processes. It covers current trends in the field, as well as strategies for the selection of the most appropriate quality control scheme. The book offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate various techniques and approaches in the validation of biopharmaceutical processes.
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
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