Process Validation in Manufacturing of Biopharmaceuticals

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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 the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be ...

Process Validation in Manufacturing of Biopharmaceuticals 2012, CRC Press, Boca Raton, FL

ISBN-13: 9781439850930

3rd edition

Hardcover

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