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The following paper presents a validation concept for cool chain transport systems of temperature-sensitive pharmaceutical products. On the one hand the validation concept is based on the measurement and evaluation of the product temperature in the insulated box during real transports. On the other hand, in simulation tests the insulated box is exposed to defined temperature profiles in a temperature chamber. The product temperature as well as the ambient temperatures measured during this process are compared with the temperatures meassured during real transports. The goal of this validation concept is to ensure that the product temperature in insulated boxes does not exceed and/or falls below the defined limits. Furthermore, it proves that the insulated box has sufficient safety reserves for the transport of cool chain-requiring pharmaceutical products. This is proven by the comparison of the amount of energy Q needed to maintain a required product temperature.