By Petter Mörée, Seeq Corporation
As the biopharmaceutical industry has continued to grow and evolve, so has the regulatory and scientific infrastructure designed to support its safety and efficacy. Continued process verification (CPV), also referred to as Ongoing process verification (OPV), is a comprehensive analysis of end-to-end production components and processes data, meant to ensure that a commercial process remains in a state of control. Typically, this means evaluating every batch and process iteration to verify that a product meets its critical quality attributes (CQAs), as well as monitoring a process for any deviations that may impact product safety or quality.
Generally, companies approach CPV as they would annual or quarterly product reviews (APRs and QPRs), treating this regulatory requirement as a documentation exercise and only investing as much time and effort as necessary to create a suitable data package for the FDA or EMA. This attitude toward CPV neglects the potential this validation step has for informing better, more agile, more optimized manufacturing. When implemented correctly using advanced analytics solutions, CPV can afford companies invaluable insights that enable increased productivity, reduce warehouse and materials costs, and support iterative process improvements.