2017~2019年辽宁省药品GMP检查质量控制缺陷分析

Quality Control Deficiencies Analysis of Drug GMP Inspection of 2017-2019 in Liaoning Province

目的对近年辽宁省药品认证检查过程中发现的质量控制相关缺陷进行汇总和分析,为监管和行业提供参考。方法对辽宁省2017~2019年认证的197家次企业的质量控制缺陷进行汇总,对高频缺陷进行归纳和分析。结果与结论药品上市许可持有人或受托方应在人员培训、计量校验、实验室管理方面加强力度,控制检验环节质量风险。

OBJECTIVE To summarize and analyze the deficiencies of quality control found in the process of drug certification inspection in Liaoning province in recent years, so as to provide reference for supervision and industry. METHODS The quality control deficiencies of 197 times certified by Liaoning province from 2017 to 2019 were summarized, and the high-frequency deficiencies were summarized and analyzed. RESULTS AND CONCLUSION The system of permit-holders for the sale of pharmaceuticals(MAH) or the consignee should strengthen the training of personnel, measurement and verification, laboratory management, to control the risk in quality control.