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




Author: Gail Sofer
Type: eBook
Date Released: 2000
Format: chm
Language: English
Page Count: 402
Isbn10 Code: 0824702492
Isbn13 Code: 9780824702496


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.

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