GB/T 28842-2021Operation specifications for medicinal product cold chain logistics (English PDF)

1 Scope

This Document specifies the general requirements; personnel and training; facilities, equipment and verification management; temperature monitoring and control; logistics operations; emergency management; internal audit and improvement; and the like requirements for the medicinal product cold chain logistics.

This Document applies to medicinal product cold chain logistics services and management.

2 Normative References

The provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document.

GB/T 34399 Temperature control facilities of pharmaceutical products cold chain logistics - Specification for performance qualification

WB/T 1097 General specification for cold-chain insulated container of drug

WB/T 1104 Road transport - Requirements of refrigerated vehicle functions for pharmaceutical products

3 Terms and Definitions

For the purposes of this Document, the following terms and definitions apply.

4 General Requirements

4.1 Appropriate management and operational personnel shall be available, and personnel shall receive appropriate training.

4.2 Appropriate temperature control facilities and equipment shall be available, and these facilities and equipment shall be validated.

4.3 A temperature monitoring system shall be available to monitor and record the temperature throughout the entire logistics operation process; and the temperature data shall be traceable.

4.4 A quality management system document for medicinal product cold chain logistics shall be established, and operations shall meet the requirements of Clause 8.

4.5 An emergency management system shall be established and implemented.

4.6 An internal audit system shall be established, and corresponding improvement measures shall be developed based on the conclusions.

4.7 All original records and vouchers in the medicinal product cold chain logistics operation process shall be kept for at least 5 years. Paper records shall be clearly visible and prevented from fading; and electronic data and records shall be backed up off-site.

5 Personnel and Training

5.1 A quality management department shall be established and staffed with dedicated quality management personnel.

5.2 Pre-employment and annual health checks shall be conducted for personnel who directly handle medicinal products; and health records shall be established.

5.3 An annual training plan shall be developed, training shall be conducted according to the plan, training records shall be kept, and training shall be evaluated.

5.4 Training content shall include, but is not limited to, relevant laws and regulations, professional knowledge, job operation procedures, safety protection, and emergency drills, and cold chain logistics personnel can only be employed after passing an assessment.

6 Facilities, Equipment, and Verification Management

6.1 Cold storage warehouse, refrigerated trucks, refrigerated boxes, insulated boxes, or other dedicated temperature control facilities and equipment appropriate to the types of medicinal products and the scale of business operations shall be available.

6.2 The performance verification of temperature control facilities and equipment shall meet the requirements of GB/T 34399 and be used within the scope supported by verification results.

6.3 Cold storage warehouse shall be equipped with power failure alarms, standby generator sets, or dual-circuit power supplies. Standby generator sets shall be inspected and maintained regularly, and start-up and operation tests shall be conducted at least once a month, with records kept.

6.4 Refrigerated trucks shall comply with the provisions and requirements of WB/T 1104.

6.5 Insulated boxes shall comply with the provisions and requirements of WB/T 1097.

6.6 Extreme temperature environmental condition verification shall be conducted on different models of in-use refrigerated trucks, refrigerated boxes, and insulated boxes within the annual cycle. While ensuring consistency, the verification of in-use refrigerated trucks, refrigerated boxes, and insulated boxes of the same model and batch can be reasonably optimized according to the actual situation of the enterprise.

6.7 Verification control documents shall be established, including but not limited to verification plans, verification schemes, verification reports, change control, deviation handling, etc. Verification control documents shall be kept as required.

6.8 When the temperature exceeds the warning temperature during logistics operations, the automatic temperature monitoring system shall issue an alarm in real time.

7 Temperature Monitoring and Control

7.1 When temperature deviations occur in cold chain logistics operations, the enterprise's quality management department shall be notified; and deviation handling shall be carried out in accordance with the requirements of the quality management system documents.

7.2 Temperature shall be monitored in real time. Temperature monitoring data shall be readable and archived. It shall be backed up off-site daily. The backup data storage location shall be secure.

8 Logistics Operations