Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality. While risk assessment involves analyzing, mitigating, communicating, and monitoring risks that could ultimately affect patients, the business, and compliance, CPV involves monitoring and analyzing manufacturing processes to ensure they remain in a state of control. CPV also helps to identify and prevent deviations, ensuring product quality and compliance.

Both risk assessment and CPV are critical to quality, operations, and compliance. Both use large amounts of product knowledge and process data, yet the industry appears to have missed the connection between the two. One reason could be that risk assessment and CPV are still manual and independent processes in most pharmaceutical companies. Yet both data sets are connected, and risk assessment data are an important subset of CPV at a granular risk level.

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