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1. Process Validation in Manufacturing of Biopharmaceuticals

   Guidelines, Current Practices, and Industrial Case Studies

   By Gail Sofer

   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
2. Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

   Edited by Anurag S. Rathore, Gail Sofer

   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
3. Process Validation in Manufacturing of Biopharmaceuticals

   Guidelines, Current Practices, and Industrial Case Studies, 2nd Edition

   Edited by Gail Sofer

   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