Shelf Life Determination for Combination Medical Device Products

Summary The shelf life for a combination product is determined from drug stability, device aging, and sterile barrier aging with the shortest estimate determining the overall shelf life. The shelf life of a product may vary between different countries/regions depending on regulatory requirements. Accelerated aging studies can be used for shelf life determination but must later be verified using data from the long-term storage conditions. Lastly, great attention should be paid in proper study design and early logistics as it is often unachievable to go back in time to fix a mistake or disagreement with agencies after several months or years have passed after a study has launched.

Best Practices • Best Practices • Data Analysis • Determination • Life Cycle • Parameters • Protocols • Regulatory • Shelf-Life • Statistics • Study Design