Pharmaceuticals in Transit

By Christian Strauch, Senior Surveyor, Pharma Claims Expert, Battermann & Tillery GmbH, IUMI Professional Partner,

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Research, development and production of a drug usually lies in the hands of a pharmaceutical company. This circumstance changes the moment the product leaves the manufacturer’s facilities and their sphere of influence and is handed over to logistics service providers for shipment. This can pose a significant challenge given the strict requirements surrounding temperature-sensitive products.

Full documentation of compliance with the required temperatures is indispensable. Deviations, grey areas or recording gaps often lead to a total loss of the goods. The qualified person, who decides on whether pharmaceuticals are released for sale, confirms the efficacy, quality and safety of a medicinal product prior to its release and is prohibited by law from releasing questionable pharmaceuticals. To continue with the example of temperature-sensitive pharmaceuticals, a significant deviation from the required temperature ranges generally gives rise to concerns. If a recording gap results in a grey area that cannot be resolved, impairment of the goods cannot be ruled out. In this case, the qualified person is obligated to assume a worst-case scenario, which often results in the destruction of the goods.

Incorrect or incomplete temperature recordings can result from technical failures. Even very mundane reasons, such as incorrectly placed sensors can trigger inaccurate or incomplete temperature records. In such cases, additional data loggers installed close to the product can provide reliable information. Recording devices installed in conveyances generally record ambient temperatures. In the event of short temperature fluctuations, the ambient temperature changes much more rapidly than the temperature in the immediate vicinity of the product. If sub-optimum temperatures temporarily prevail by mistake, and the error is detected and corrected swiftly, data loggers can be used to prove that the temperature of the cargo remained in the required range.

In conclusion, the use of data loggers makes sense for the transport of temperature-sensitive pharmaceuticals. Their primary purpose is to provide a complete record of the temperature throughout transit thus enabling informed decisions regarding the usability and marketability of a product. As a result, very costly total losses may be averted.