Continued process verification (CPV) is a critical phase of process validation to ensure on-going confirmation of the validated state of the designed process. There have been regulatory guidelines and other industry consortium approaches proposed to enable effective CPV using a variety of statistical process control techniques. In this paper we will propose a new approach we call enhanced CPV, or eCPV, which utilizes real-time multivariate statistical process monitoring technology. This approach not only enables a real-time view into the process but also allows monitoring and understanding of the interactions that are defined in the operational space. We will demonstrate the methodology and illustrate through industrial case studies with upstream and downstream applications from biopharmaceutical manufacturing

Multivariate process monitoring towards enhanced continued process verification

251st National Meeting (2016)

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