GB/T 28842-2021 (English Version)

Standard No.: GB/T 28842-2021
Language: Chinese, Available in English version
Release Date: 2021
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 28842-2021
Replace: GB/T 28842-2012

Scope: This document specifies the general requirements for the cold chain logistics process of pharmaceuticals, personnel and training, facilities and equipment and verification management, temperature monitoring and control, logistics operations, emergency management, internal audit and improvement, etc. This document applies to pharmaceutical cold chain logistics services and management.

Introduction

Core changes in the standard revision

Dimensions	2012 Edition	2021 Edition
Definition of terms	Includes 3 terms such as "refrigerated drugs"	Simplified to a single definition of "drug cold chain logistics"
Verification management	Basic verification requirements	Added Verification optimization principles for equipment of the same model
Record retention	Unspecified period	Required to be retained for at least 5 years

Key points for implementation of key elements

1. Verification of temperature control facilities

According to the requirements of GB/T34399, refrigerated trucks need to be verified in extreme temperature environments, and equipment from the same batch can be sampled for verification. The verification document should include:

Annual verification plan
Equipment performance confirmation report
Temperature deviation processing record

2. Logistics operation specifications

Receiving link case:

A biological product company implemented a "dual temperature verification" mechanism, and simultaneously verified the insulated box upon arrival:

Integrity of transportation temperature records
On-site infrared thermometer review
Complete in-warehouse transfer within 30 minutes

Technology evolution analysis

The new version of the standard reflects three major trends:

Direction	Specific performance
Risk control	New temperature deviation handling process (Article 7.1)
Process traceability	Mandatory data backup requirements (Article 7.2)
Quality extension	Special regulations for air transport (Article 8.3.6)

Enterprise implementation suggestions

1. System construction steps

Establish a three-level document system (manual/procedure/record)
Configuration of temperature monitoring system must meet the following requirements:
- ±0.5℃ accuracy
- 5-minute recording frequency
- Dual backup storage
Quarterly emergency drills

2. Key points of compliance inspection

Verify document integrity (Article 6.7)
Training record retention period (Article 5.3)
Cold storage backup power supply test records (Article 6.3)

GB/T 28842-2021 Referenced Document

GB/T 34399 Temperature control facilities of pharmaceutical products cold chain logistics－Specification for performance qualification
WB/T 1097 General Specifications for Pharmaceutical Cold Chain Insulation Boxes
WB/T 1104 Functional configuration requirements for refrigerated trucks for road transportation of pharmaceutical products

GB/T 28842-2021 history

2021 GB/T 28842-2021 Operation specifications for medicinal product cold chain logistics
2012 GB/T 28842-2012 Operation specification for drug cold chain logistics