GB/T 46204-2025

Active

Requirement for traceability management in medicinal product cold chain logistics

药品冷链物流追溯管理要求

Standard Type
GBT
ICS
03.220.01
CCS
A 80
Status
Active
Issue Date
2025-10-05
Implementation
2025-10-05
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 traceability management requirements for the entire cold chain logistics process of medicinal products, including temperature monitoring, data recording, and information sharing. It is applied by pharmaceutical manufacturers, logistics providers, and healthcare institutions in China to ensure the integrity of temperature-sensitive drugs, such as vaccines and biologics, during transportation and storage. The standard supports compliance with regulatory audits and facilitates rapid recall or investigation in case of temperature excursions.

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.