Publisher's Synopsis
A must-have reference for scientists in both industry and academia, this Third Edition includes completely revised and updated sections on validation in multi-national and small companies, issues pertaining to the Code of Federal Regulations 21, process analytical technology, real-time monitoring, practitioner compounding, and European and Japanese approaches to validation. The fundamental concepts of validation are explicitly discussed including calibration and metrology, temperature measurements, validation of water systems as well as qualification and significant aspects of change control.
