The shelf life or the expiration date of a combination product is determined by the shortest estimated shelf life of the stability testing including drug stability, device aging, and packaging system/ sterile barrier aging. The stability testing provides regulatory agencies with critical information for approval, assure product quality throughout the storage period, provides health care providers with product label instructions for storage period and condition, and provides patients with confidence in the product safety.
STEMart provides a variety of stability testing services to help manufacturer determine the shelf life of their combination product. https://www.ste-mart.com/stability-testing.htm
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