White Paper

Demystifying Performance Testing: Strategies To Qualify Combination Products

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.

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Med Device Online? Subscribe today.

Subscribe to Med Device Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Med Device Online

West Pharmaceutical Services, Inc.