PDA Technical Report 64 (TR 64): Active Temperature-Controlled Systems: Qualification Guidance
TR-64 addresses best practices for qualifying temperature-controlled trucks or trailers, temperature-controlled ocean containers, active unit load devices and walk-in temperature-controlled stores that are used to quarantine, hold or store raw materials, intermediates or products.
The report also identifies best practices for performing and documenting the qualification activities, including temperature mapping studies that are part of an overall validation program.
