New USP Chapter <1079.5> Transportation Lane Temperature Mapping and Qualification Published for Comments

In the Pharmacopeial Forum, PF 51(5), a proposal for a new USP General Chapter <1079.5> Transportation Lane Temperature Mapping and Qualification, as well as an accompanying Stimuli article entitled "Transportation Lane Temperature Mapping and Qualification—Risk Identification and Evaluation", were published.

New Chapter <1079.5>

Although the transportation times of drug products are generally much shorter than storage times, the environmental fluctuations during transport, such as temperature extremes, may have a high impact on product integrity. Therefore, transportation modes, routes, and systems may need to be evaluated to identify risk areas and to assess the effectiveness of mitigation strategies.

According to the briefing notes, "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."

The new chapter is structured as follows:

• 1. Introduction
• 2. Scope
• 3. Determine the Transportation Lane
• 4. Preparation
  4.1 Preparation—Selection of Lanes
  4.2 Preparation—Frequency
  4.3 Preparation—Temperature Monitoring Devices
  4.4 Preparation—Mapping Protocol
• 5. Execution
• 6. Data Evaluation and Qualification
• 7. Final Report
• 8. Lane Management—Complaints, Supplier Changes, Weather Changes, New Lanes, and Reevaluation
• 9. Conclusion
• References
• Additional Sources of Information

It "applies to every supply chain partner from the manufacturer through any entity that stores or holds a finished drug product, with the sole exception of the patient." Examples mentioned are:

• Manufacturers
• Repackaging operations
• Healthcare providers and institutions 
• Pharmacies
• Importers and exporters
• Wholesale distributors
• Third-party logistics providers
• Brokers
• Freight forwarders

It is pointed out that "manufacturers of active pharmaceutical ingredients, excipients, medical devices (excluding drug combination devices), and dietary supplements are not within the scope of this chapter. However, the principles presented may be useful for materials other than finished drug products."

Stimuli Article

The Stimuli article, "Transportation Lane Temperature Mapping and Qualification—Risk Identification and Evaluation", provides additional background and context for the development of Chapter <1079.5>. It describes the use of temperature mapping as a process to evaluate and qualify transportation lanes to maintain drugs within appropriate temperature ranges.

Topics covered include:

• Developing a Strategy and Protocol for Temperature Lane Mapping
• Determine the Transportation Lane: Preparation and Selection
• Determining the Frequency of Lanes to be Mapped
• Data Evaluation and Qualification
• Lane Management

Links to Other USP Chapters

The new USP chapter and the Stimuli article contain references to other relevant USP chapters which are important in this context and should be taken into account, in particular:

• <659> Packaging and Storage Requirements
• <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
• <1079.3> Monitoring Devices—Time, Temperature, and Humidity
• <1079.4> Temperature Mapping for the Qualification of Storage Areas

Download and Comments

The documents can be viewed free of charge after registration on the Pharmacopeial Forum website. Comments can be submitted until 30 November 2025.