BRIEFING

 〈1079.5〉 Transportation Lane Temperature Mapping and Qualification. The General Chapters—Packaging and Distribution Expert Committee is proposing this new general chapter, which addresses the importance of maintaining drug product stability during transportation. The extent of physicochemical degradation of drug products depends on factors such as product stability and storage conditions. The transportation environment is critical for maintaining the product and is often outside the direct control of the shipper, including manufacturers, distributors, freight forwarders, and healthcare providers.

 It is essential for shippers to understand the environment to which the product will be exposed and ensure that it remains within the conditions supported by product stability data and Packaging and Storage Requirements 〈659〉. Temperature lane temperature mapping is a technique used to evaluate the effectiveness of transportation modes and lanes in maintaining acceptable temperatures. Proper use of temperature lane mapping can help determine whether those modes and lanes maintain appropriate temperatures and identify areas that may require mitigation.

 This proposed chapter provides best practices for the mapping, evaluation, and qualification of transportation modes and lanes to maintain temperature, ensuring that drug products remain within the required temperature ranges throughout the transportation process. This chapter does not cover qualification of controlled temperature systems such as packing and vehicles.

 Also published in this issue of PF is a Stimuli article, Transportation Lane Temperature Mapping and Qualification—Risk Identification and Evaluation, that provides additional background and context for the development of this chapter.

 (GCPD: D. Hunt)

 Case ID—SUB-2207