关键词: 药品现代物流企业, 药品经营许可核发现场检查, 缺陷分析, 建议

Abstract:

Objective： Analyze the current situation of on-site inspection for the issuance of drug distribution licenses for modern logistics enterprises in Jiangxi province in 2023， in order to provide reference for standardizing the development of modern pharmaceutical logistics enterprises.Methods： Summarize the quality risk data of on-site inspection for the issuance of drug distribution license for modern logistics enterprises in Jiangxi province in 2023， summarize and analyze common problems found during the on-site inspection， and put forward.Results： In 2023， Jiangxi Provincial Drug Certification and Evaluation Center accepted 65 applications for the issuance of drug distribution license for modern logistics enterprises， and found 360 defects items （5 serious defects items， 172 major defects items， and 183 general defects items）， mainly in personnel and training， quality management system documents， facilities and equipments， quality management system， computer systems， and other aspects.Conclusion： Modern pharmaceutical logistics enterprises should strengthen the sense of corporate responsibility， continuously improve quality management system， enhance personnel training， improve software and hardware facilities and equipments， enhance quality control level， in order to achieve long-term high-quality development.

Key words:  , Modern logistics enterprises； , On-site inspection for drug distribution license issuance； , Defect analysis； , Suggestion