Continued Process Verification: Monitoring and Maintaining a State of Control

by Kate Lusczakoski, PhD
Volume 14, Issue 1 (Spring 2015)

To ensure that a commercial biomanufacturing process is in a state of control, life science companies must create and successfully execute initiatives to meet continued process verification (CPV) and other monitoring guidelines. Management at pharmaceutical, biotech, and medical device companies commonly receive directives associated with data monitoring. Various challenges arise in the development and maintenance of a successful global monitoring program. Because of this, many companies develop data monitoring programs that are not scalable and sustainable. Company leaders struggle with how best to adopt, deploy, and scale monitoring systems to achieve defined quality monitoring goals. The purpose of this article is to display a maturity model to help companies navigate the major steps of implementing a global monitoring plan for continued process verification.

Lusczakoski K. Continued process verification: monitoring and maintaining a state of control. BioProcess J, 2015; 14(1): 36–42.

Posted online April 29, 2015.