贵州省药品经营企业许可证有效期满换证现场检查缺陷情况分析OA

Objective To provide a reference for regulatory authorities in formulating the renewal management measures for the expiration of the Drug Distribution License of drug distributors(referred to as renewal upon expiration).Methods Based on the on-site inspections conducted by the Inspection Center of Guizhou Provincial Medical Products Administration in 2024 on 200 drug distributors applying for renewal upon expiration,the problems existing in drug management of drug distributors applying for renewal upon expiration and their causes were analyzed,and the strategies to improve regulatory efficiency were explored.Results Among the 200 renewal-upon-expiration enterprises,including 164 drug wholesale enterprises and 36 drug retail chain headquarters,which were mainly concentrated in Guiyang City(49.39%,33.33%);drug wholesale enterprises and drug retail chain headquarters had 1 268 and 445 defects respectively,mainly distributed in the sections of quality management system documents,organizational structure and quality management responsibilities,among which drug wholesale enterprises were also mainly distributed in the sections of personnel and training,facilities and equipment,and storage and maintenance,while drug retail chain headquarters were also mainly distributed in the sections of retail display and storage and retail facilities and equipment;there were 22 serious defects,among which drug wholesale enterprises mainly had insufficient control over the sales link,and drug retail chain headquarters mainly had untraceable business operations of stores and purchases with expired qualifications not intercepted by computer system;there were 826 major defects,among which drug wholesale enterprises mainly had insufficient management and control over computer systems,and drug retail chain headquarters mainly had non-standard prescription drug sales and storage management;there were 806 general defects,among which both drug wholesale enterprises and drug retail chain headquarters mainly had inaccurate quality management system documents;there were 59 other defects,among which drug wholesale enterprises mainly did not meet the Guizhou Provincial Modern Logistics Technical Guidance Principles for Drug Wholesale Enterprises,and drug retail chain headquarters mainly did not meet the Measures for the Supervision and Administration of Drug Distribution and Use.The main causes include disconnection between document design and actual business,lack of personnel training and assessment mechanisms,untimely updates of documents and management measures,drug wholesale enterprises remaining in traditional management models,and drug retail chain headquarters neglecting quality management,etc.Conclusion Common problems in the renewal on-site inspections of drug wholesale enterprises and retail chain headquarters in Guizhou Province have commonalities and differences.Regulatory authorities should strengthen policy guidance,increase supervision and inspection efforts,and combine new technologies such as artificial intelligence to guide the standardized,large-scale,and modern development of distributors.Enterprises should strengthen the awareness of main responsibility and enhance the construction of drug distribution quality management systems.