Defining Patient-Centric Specification in a Risk-Based Control System

Defining limits for analytical method outputs is a central element of a control strategy. Traditional approaches usually focus on ensuring process consistency, while in more advanced approaches the understanding of structural-function relationships are utilized. This enables definition of patient centric limits that focus on controlling the impact of CQAs on product efficacy and patient safety. In certain cases, those limits and can be defined independent from a specific analytical method and where indicated can extend beyond a therapy specific clinical history. Process consistency control and change management are an integral part of the patient-centric specification and risk-based control strategy approach. The presentation will provide some practical examples for the definition of patient-centric specifications and process consistency control.