Implementation of Patient Centric Specifications from an Industry & Regulator Perspective
Over the past twenty years, an evolution of pharmaceutical development has resulted in new approaches to ensuring product quality and patient safety. The science and risk-based concepts outlined in ICH Q8-Q12 encourage a more holistic approach to the product control strategy. Under this paradigm, product quality should not be ensured by the quality specification, rather it should be confirmed. Over-reliance on batch history for setting specification limits at the time of registration may result in limits that are too tight if manufacturing experience at the time of registration is minimal and batch data ranges are very narrow. Push back from regulators could force pharmaceutical manufacturers to Introduce additional purification steps that would lead to products meeting the tighter limits with concurrent loss in product yield. In turn, this may also result in unnecessary product rejection and/or increased manufacturing costs. Conversely, over-reliance on batch history might discourage companies to consistently manufacture material of the highest quality for clinical batches, to later enable a justification for wider limits for the registration specifications. Finally, this reliance on batch data could conflict with the current regulatory environment to expedite clinical studies through the Breakthrough therapy designation or Prime pathways.
