A pharmaceutical company is firstly responsible for the research, development and production of a drug. Yet, this changes the minute the product departs the manufacturer’s facilities, as now responsible is the logistics service providers for its shipment.
Specifically, according to Battermann and Tillery Group this poses a great challenge due to the strict requirements surrounding temperature sensitive products.
It is of a great importance to provide the shipper with full documentation of compliance with the required temperatures, keeping in mind that there’s a responsible person deciding on the sale, efficacy, quality and safety of a medical product, who’s prohibited by law from releasing questionable pharmaceuticals.
Therefore, temperature-sensitive pharmaceuticals should be carefully shipped.
In the possibility that 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.
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In addition, false or incomplete temperature recording could lead to technical failures. 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 a case of shore temperature fluctuations, the ambient temperature changes much more rapidly than the temperature in the immediate vicinity of the product.
Concluding, data loggers are of a great importance, since they provide a complete record of the temperature throughout transit thus enabling informed decisions regarding the usability and marketability of a product.
