GB/T 34399-2025

Active

Temperature control facilities validation for pharmaceutical products cold chain logistics—Technical specification for performance qualification

医药产品冷链物流温控设施设备验证 性能确认技术规范

Standard Type
GBT
ICS
55.180.99
CCS
A 80
Status
Active
Issue Date
2025-08-01
Implementation
2025-08-01
Centralized Committee
国家标准委
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the technical requirements for performance qualification of temperature-controlled facilities and equipment used in pharmaceutical cold chain logistics. It is applied to validate the performance of refrigerated storage, transportation vehicles, and temperature-controlled packaging systems to ensure they maintain required temperature ranges during drug distribution. The standard is primarily used by pharmaceutical manufacturers, logistics providers, and regulatory bodies in China for compliance testing and quality assurance of cold chain operations.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.