GB/T 34399-2025 Temperature control facilities validation for pharmaceutical products cold chain logistics - Technical specification for performance qualification English, Anglais, Englisch, Inglés, えいご
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ICS 55.180.99
CCS A 80
National Standard of the People’s Republic of China
GB/T 34399-2025
Replaces GB/T 34399-2017
Temperature control facilities validation for pharmaceutical products cold chain logistics -
Technical specification for performance qualification
Issue date: 2025⁃08⁃01 Implementation date: 2025⁃08⁃01
Issued by the State Administration for Market Regulation
the National Standardization Administration
Contents
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Assurance requirements
5 Performance validation of temperature-controlled warehouse
6 Performance validation of temperature control chamber
7 Performance confirmation of temperature-controlled vehicles
8 Performance validation of refrigerator
9 Performance validation of insulated container
10 Performance validation of temperature monitoring system
11 Confirmation method
Annex A (Informative) Calculation method of temperature deviation, uniformity and fluctuation
Bibliography
Temperature control facilities validation for pharmaceutical products cold chain logistics –
Technical specification for performance qualification
1 Scope
This document specifics the assurance requirements for performance confirmation of temperature-control facilities and equipment for cold chain logistics of pharmaceutical products, the requirements for performance confirmation of temperature-controlled warehouses[1) Note: temperature control box includes refrigerator, freezer, etc.]1), temperature-controlled cabinets, temperature-controlled vehicles, refrigerators, incubators and temperature monitoring systems, as well as the verification methods.
This document is applicable to activities such as performance validation of temperature-controlled warehouses, temperature-controlled cabinets, temperature-controlled vehicles, refrigerators, insulated container and temperature monitoring systems involved in the verification process of temperature-controlled facilities and equipment for pharmaceutical chain logistics
2 Normative references
This document contains no normative references.
3 Terms and definitions
The following terms and definitions are applicable to this document.
3.1
performance qualification
activity of testing, verifying, and documenting to confirm that the installed and connected facilities, systems, and equipment can operate effectively and stably in accordance with the approved production methods and technical requirements of the products
3.2
temperature-controlled cabinet
small storage container with temperature control function
3.3
refrigerator
insulated box with temperature control function.
3.4
insulated container
heat insulation box body made of heat insulation material.
3.5
temperature monitoring system
system composed of monitoring terminals, management hosts, uninterruptible power supplies, and related software, which can collect, display, gather, process, record, alarm, and transmit temperature data of pharmaceutical products in real time during storage and transportation.
4 Assurance requirements
4.1 Personal requirements
Personnel participating in performance qualification activities shall receive corresponding training and be familiar with relevant laws, regulations, and professional skills.
Note: Personnel participating in performance qualification activities include but are not limited to supervisors, instructors, coordinators, approvers, and executors.
4.2 Requirements for verifying samples
4.2.1 The temperature recorder or verification management system for verification should have the functions of data storage, export and viewing, and can prevent users from modifying or reversing human data.
4.2.2 The temperature recorder for verification should have the function of uninterrupted data acquisition and recording, and the interval between data acquisition should not be greater than 1min.
4.2.3 The measurement range of the temperature recorder for verification shall be applicable to the temperature range for performance confirmation, and the maximum allowable error of temperature measurement is ± 0.5 °C.
4.2.4 The temperature recorder for verification shall be regularly calibrated by a legal measurement institution and affixed with a calibration qualified label.
