This Stimuli article describes the use of temperature mapping as a process to evaluate and qualify transportation lanes to maintain drugs within appropriate temperature ranges. It is an effective strategy to identify risks as part of a quality management system (see Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products 〈1079〉). The new USP chapter, Transportation Lane Temperature Mapping and Qualification 〈1079.5〉, is being developed to give specific guidance on this topic.
The extent of physicochemical degradation of drug products depends on factors such as product stability, including how a product is transported. Transportation modes and lanes need to be evaluated to ensure the product is maintained within appropriate temperature ranges, ensuring product efficacy and expiry. Many factors impact the ability of transportation modes to maintain acceptable temperature ranges (see Packaging and Storage Requirements 〈659〉), including the mode type (e.g., ground vehicles, air, rail, and ocean), temperature control, transportation mode insulation, airflow, door usage (e.g., frequency and time that doors are open), geography, season, transportation time, and delays (e.g., traffic, weather, customs, and border crossings).