GB/T 34399-2025 Temperature control facilities validation for pharmaceutical products cold chain logistics—Technical specification for performance qualification
GB/T 34399-2025 Temperature control facilities validation for pharmaceutical products cold chain logistics—Technical specification for performance qualification
Basic Information
Scope
This document specifies the quality assurance requirements for the performance verification of temperature control facilities and equipment in the cold chain logistics of pharmaceutical products, including the requirements for the performance verification of temperature-controlled warehouses, temperature-controlled cabinets, temperature-controlled vehicles, refrigerated boxes, insulated boxes, and temperature monitoring systems, as well as the verification methods.
This document applies to activities such as the performance verification of temperature-controlled warehouses, temperature-controlled cabinets, temperature-controlled vehicles, refrigerated boxes, insulated boxes, and temperature monitoring systems involved in the validation process of temperature control facilities and equipment in the cold chain logistics of pharmaceutical products.