PDA TR 64

Fundamental to any temperature-controlled process is the expectation that materials that are stored and shipped within a controlled environment are maintained within a defined temperature range. Typically, this temperature range is within the recommended product storage requirements derived from stability data. This guidance discusses the process of qualifying actively controlled spaces that are designed to maintain a stable and uniform temperature around the cargo for the duration of transportation or storage at any temperature range. Specifically, this guidance addresses best practices for qualifying temperature-controlled trucks or trailers (hereafter referred to simply as "trucks"), temperature-controlled ocean containers, active ULDs, and walk-in temperature-controlled stores that are used to quarantine, hold, or store raw materials, intermediates, or products. It provides details on selected temperature-controlled units and their qualification testing, and it identifies best practices for performing and documenting the qualification activities, including temperature mapping studies, that are part of an overall validation program, whether that program is conducted by the pharmaceutical shipper or a service provider.