By Daniel Bantz, Jennifer L. Riter, T. Page McAndrew; West Pharmaceutical Services, Inc.
Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first. It is essential for the FMEA to be a living document, for the purpose of tracking risks that are mitigated, and new risks that are identified. This approach not only enables continuity between past and future data sets, it harmonizes data across departments, organizations, and businesses. The result is a best performing combination product, that has efficient approval, and most important, meets patient needs.