Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies




eBook Title for Download :Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Format : chm , Language : English)

Plot :

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 product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.



Author(s) Book :Gail Sofer
Publish Year :2000 Publisher : Informa Healthcare
You can check by ISBN10/ISBN13 : 0824702492/9780824702496
Pages :402

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