Shelf Life Determination for Combination Medical Device Products
By Liu, Jian, Chiesl, Thomas, and Kamberi, Mark
Published in: Journal of GXP Compliance, Nov. 2018, Vol.2216
Published on: August 22, 2018
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.
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