15/16 November 2023
The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.
Clinical trials (CTs) are studies that are performed to determine if an Investigational medicinal product (IMP) meets the effectiveness and safety criteria as has been outlined in the CT protocol. IMP distribution differs from commercial distribution in that the quantities for IMPs are often very small and there are numerous final destinations, such as clinics and remote clinical settings. Another difference from a commercial drug product is the (un)known stability of the IMP that is often a new chemical/molecular entity in the early stages of CTs and has not been through the whole ICH stability program. The IMP also creates another unique challenge, which is ensuring the proper distribution of every packaging system, because a temperature excursion may jeopardize the entire CT outcome.
When shipping IMPs to depots and CT sites, using common shipping lanes and within appropriate temperature zones, a risk assessment can identify the probability and the impact missteps in the supply chain. ICH Q9 presents some risk assessment tools that can be used to help organizations to identify their risks and how to address them. Factors such as product category, duration of journey, shipping container (e.g., if temperature-controlled), and type of vehicle should be taken into consideration. According to the USP, organizations should also evaluate if delays along the transportation route or due to custom holds can increase risk rates and should propose mitigation strategies. In addition, track & trace technologies that permit the trial sponsor, packaging contractor, clinical research organization, and the clinical trial site to monitor (track) the IMP along the supply chain can be used. Further details for mitigating risks are provided in USP chapter <1079>.
More information is available in the USP-NF.