We are living longer than ever before. We are healthier than ever before. We have more doctors, hospitals, medicines and health products than ever before. But, we have a problem with continuing to make these improvements. It still takes too ...
Year: 2013
Discussion Regarding FDA Guidance for Industry on Process Validation: General Principles and Practices, January 2011, Current Good Manufacturing Practices (CGMP) Revision ...
Year: 2013
MES and Electronic Batch Recording (EBR) have become critical business applications for most large and mid-size pharmaceutical manufacturers. The initial implementations of these technologies focused on translating the paper batch record to something filled out on a computer (Paper on ...
Year: 2013
Genentech Process Technical Development has come a long way in the past 5 years. Migrating from local on the floor trending on dedicated workstations to desktop and terminal server based Processbook displays was a big step forward. However, Coresight represents ...
Year: 2013
The PAT and QbD initiatives increase the demand on adapted process monitoring and control techniques within pharmaceutical and biopharmaceutical industries. Multivariate statistical process monitoring is a well suited technique which for many years has been used for real-time monitoring and ...
Year: 2013