Pharmaceuticals in Transit By Christian Strauch Senior Surveyor, Pharma Claims Expert Battermann & Tillery GmbH Research, development and production of a drug are in the hands of a pharmaceutical company or their contract manufacturer. The processes and procedures are thereby subject to their direct monitoring and control. Generally speaking, this circumstance changes at the moment the product leaves the manufacturer’s facility and is dispatched for transport to an affiliate or customer. The pharmaceuticals are generally then handed over to logistics service providers and thus leave the direct sphere of influence of the manufacturer, who, however, is still obligated to ensure that the goods reach the respective consignee in the quality and quantity stipulated. This can pose a significant challenge given the strict requirements surrounding temperature-sensitive products. Full documentation of compliance with required temperatures is indispensable in order to be able to trade temperature-sensitive pharmaceuticals. The occurrence of deviations, grey areas or recording gaps often leads to a total loss of the goods. In order to illuminate the situation, it is worthwhile here to consider the perspective of the Qualified Person, usually someone from the Quality Control/Assurance staff, who decides on the release to the market. This person confirms the efficacy, quality and safety, which is ultimately the prerequisite for marketability, of the products. Conversely, this person is prohibited by law from releasing questionable pharmaceuticals for trade. To continue with the example of temperature-sensitive goods, a significant deviation from the required transit temperature range is often accompanied by impairment to / dubiousness of the goods. If a recording gap results in a grey area that cannot be resolved afterwards, an impairment of the goods cannot be ruled out. In this case, a worst-case scenario is to be assumed, which often results in the destruction of the affected consignment. This can mean that incorrect, insufficient or incomplete data can result in a total loss. Reasons for incorrect or incomplete temperature recordings can be of a technical nature. Although logistics service providers specialising in the transport of pharmaceuticals have to inspect and calibrate the equipment much more closely, technical failure can never be completely ruled out. 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 within the consignments can provide reliable information about the temperatures to which a product has been exposed. This can not only limit recording gaps that may have occurred, but also provides data that can reliably indicate the temperatures prevailing in the immediate vicinity of the product. The circumstances may also be decisive in view of the fact that recording devices installed in a conveyance generally record ambient temperatures. In the event of short temperature fluctuations, which are not uncommon, the ambient temperature changes within the cargo space much more rapidly than the temperature in the immediate vicinity of the product (due to packaging materials such as insulation, dividers, cartons etc.). It may happen, for example, that temperatures below freezing are briefly recorded inside the conveyance due to an incorrect setting. If the error is detected and corrected swiftly, data loggers can be used to prove, if necessary, that there were no unfavourable or impermissible temperatures in the immediate vicinity of the product. This means that this can allow for the release of a consignment initially thought to be lost. In this regard, it should be added that it makes sense to have more than one data logger in a shipment. This especially applies to air freight, since it is common practice for shipments to be split temporarily. If, after transport, only scant data are available which may show an unfavourable deviation, a conclusion is drawn for the entire shipment, i.e. it is assumed that all packing units for which nothing to the contrary can be proven were also exposed to unfavourable conditions (at this point, the aforementioned worst-case scenario applies again). In conclusion, the use of data loggers makes sense and is recommended 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. Therefore, potential total losses of shipments, which can be extremely costly – particularly in the case of pharmaceuticals – are in several cases able to be averted.