GB/T 34399-2017

Abolished

Temperature control facilities of pharmaceutical products cold chain logistics-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
A80
Status
Abolished
Issue Date
2017-10-14
Implementation
2018-05-01
Centralized Committee
国家标准委
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国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 verify that refrigeration units, insulated containers, temperature monitoring systems, and storage environments maintain required temperature ranges during transport and storage. The standard is primarily used by pharmaceutical logistics providers, regulatory auditors, and quality assurance teams to ensure compliance with cold chain integrity for drugs, vaccines, and biological products.

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.