Guidelines, Current Practices, and Industrial Case Studies
A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final...
Published April 23rd 2013 by CRC Press
Series: Biotechnology and Bioprocessing
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as...
Published May 8th 2012 by CRC Press
Guidelines, Current Practices, and Industrial Case Studies, 2nd Edition
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...
Published May 5th 2005 by CRC Press