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Realizing the Benefits of CPV With Advanced Analytics
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 process 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.