OBJECTIVE To analyze the quality management system of lot release institutions for vaccines, and identify the issues that still need to be improved, so as to improve the quality management system of lot release institutions and meet the evaluation requirements of WHO-NRA. METHODS Gap analysis was used to analyze the quality management system of lot release institutions in China, comparing with WHO-GBT LT and WHO-GPCL. RESULTS The framework of quality management system for biological products lot release had been built in some drug control institutions in China, but there was still much needing to be improved in laboratory management. CONCLUSION Although some progress has been made in the construction of the quality management system for the lot release system in China, it still needs to be improved from the aspects of organization, personnel training, records, sample management, facilities and equipment, audit systems, etc.
LI Dan-ping, CHEN Yan, YUAN Jun, YANG Lei, LI Yan, LI Xi, HUANG Wan-zhen, GAO Xiao-ming, XIANG Xin-hua.
Analysis of the Construction of Quality Management System in Lot Release Institutions for Vaccines in China[J]. Chinese Pharmaceutical Journal, 2021, 56(18): 1453-1455 https://doi.org/10.11669/cpj.2021.18.002
[1] International Organization for Standardization(ISO).General Requirements for the Competence of Testing and Calibration Laboratories [S]. 2017. [2] World Health Organization (WHO). Benchmarking of the National Regulatory Authority (NRA) GBT Rev VI[S]. 2019. [3] XIANG X H, ZHANG H Z, YU X, et al. Basic Framework of quality management criteria for pharmaceutical quality control laboratories[J]. Chin Pharm Aff(中国药事), 2013,24(6):584-591 [4] World Health Organization (WHO). Good Practices for Pharmaceutical Quality Control Laboratories[S]. 2009. [5] CNAS-GL011:2018 Guidance on Internal Audit for Laboratories and Inspection Bodies [S]. 2018. [6] YU X. The discussion of management review in OMCL through SWOTA analysis[J]. Chin Pharm J(中国药学杂志). 2020,55(19):1644-1648 [7] YU X. Exploration of the Internal Audit of Quality Management System in Comprehensive Drug Testing Institutes[J]. Chin Pharm Aff(中国药事), 2020,34(3):311-314.