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Clinical trial supplies management can be a notoriously difficult logistical task. The opportunity for deviation is further enhanced by having to manage the movement of cold chain material (typically classified as 2°-8°C). This article will look at the most common obstacles encountered when procuring and moving cold chain products, with a focus on comparator products.
More and more clinical trials are utilising comparator drugs and, especially in oncology, most of the existing products are cold chain. There is much to consider when moving cold chain products: gone are the days of throwing in a few gel packs and hoping for the best. The standard expected now is much higher, and correctly so. Regulatory and logistical requirements often shape the delivery protocol. Medicines requiring controlled temperature storage conditions must be distributed in a manner that always ensures that their quality will not be adversely affected. The World Health Organization’s policy on Good Distribution Practice (GDP) broadly mirrors the attitudes published by bodies such as the Food and Drug Administration (FDA), European Medicines Evaluation Agency (EMEA) and the Medicines and Healthcare products Regulatory Agency in the UK (MHRA). In essence, the regulations are harmonious. |
