GB/T 34399-2025: Temperature control facilities validation for pharmaceutical products cold chain logistics - Technical specification for performance qualification

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Scope

This document specifies the assurance requirements for the performance qualification of
temperature control facilities and equipment in the cold chain logistics of pharmaceutical
products, the requirements for the performance qualification of temperature-controlled
warehouses1), temperature-controlled cabinets, temperature-controlled vehicles, refrigerators,
insulated containers, and temperature monitoring systems, as well as the validation methods.
This document applies to performance qualification activities involving temperature-controlled
warehouses, temperature-controlled cabinets, temperature-controlled vehicles, refrigerators,
insulated containers, and temperature monitoring systems during the validation process of
temperature control facilities and equipment in the cold chain logistics of pharmaceutical
products.

Basic Data

Standard ID	GB/T 34399-2025 (GB/T34399-2025)
Description (Translated English)	Temperature control facilities validation for pharmaceutical products cold chain logistics - Technical specification for performance qualification
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	A80
Classification of International Standard	55.180.99
Word Count Estimation	14,169
Date of Issue	2025-08-01
Date of Implementation	2025-08-01
Older Standard (superseded by this standard)	GB/T 34399-2017
Issuing agency(ies)	State Administration for Market Regulation, Standardization Administration of China