GB/T 42502-2023 (English Version)

Standard No.: GB/T 42502-2023
Language: Chinese, Available in English version
Release Date: 2023
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 42502-2023

Scope: This document specifies the basic requirements for pharmaceutical logistics quality management auditors, audit work requirements, and audit content, audit judgment, audit results and feedback, evaluation and improvement requirements. This document is applicable to pharmaceutical logistics quality management auditors' audits of pharmaceutical logistics service providers.

Introduction

1. Background of standard formulation and analysis of technological evolution

GB/T 42502-2023 "Pharmaceutical Logistics Quality Management Audit Specification" is a further development of GB/T 30335 and GB/T 28842, aiming to meet the rapid development needs of the modern pharmaceutical logistics industry. With the advancement of pharmaceutical cold chain logistics technology and the improvement of regulatory requirements, this standard emphasizes the audit requirements of the quality management system to ensure that pharmaceutical logistics service providers reach a higher industry standard in terms of organizational construction, personnel training, facilities and equipment.

2. Comparison table of audit frameworks

Audit dimensions	Specific requirements	Audit basis standards
Organizational construction	Including qualifications such as business license and road transport license, as well as the establishment and responsibilities of the quality management department.	GB/T 30335, GB/T 28842
Quality management documents	Including the formulation and revision process of documents such as operations, facility and equipment management, and verification management.	GB/T 30335, GB/T 28842
Personnel and Training	Qualification of key personnel, assessment of cold chain operators, annual training plan, etc.	GB/T 30335, GB/T 28842

3. Implementation Suggestions and Case Analysis

Case 1:During the audit process, a pharmaceutical logistics service provider found that its cold storage facilities did not meet the requirements of GB/T 28842. Through technical transformation and equipment upgrades, the company not only passed the audit, but also significantly improved its cold chain logistics capabilities.

Implementation suggestions:

Establish an internal audit mechanism to ensure regular self-inspection and improvement
Strengthen personnel training, especially the professional capabilities of cold chain operators
Optimize the maintenance and upgrade plan of logistics facilities and equipment

GB/T 42502-2023 Referenced Document

GB/T 28842 Operation specifications for medicinal product cold chain logistics
GB/T 30335 Pharmaceutical logistics service specifications*， 2025-06-25 Update
GB/T 34399 Temperature control facilities of pharmaceutical products cold chain logistics－Specification for performance qualification
GB/T 35145 Cold chain temperature logger
JT/T 1325 Technical requirements and inspection methods for driving temperature recorders
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 42502-2023 history

2023 GB/T 42502-2023 Pharmaceutical logistics quality management audit specification