张艳 1李海峰 1庄辉 1侯玉磊 1田宝坤 1杨成勇1
作者信息
- 1. 山东省食品药品审评查验中心,山东 济南 250013
- 折叠
摘要
Abstract
Objective To analyze the current situation defective items in the"Quality Management System Documentation"of pharmaceutical trading enterprises in Shandong Province.Methods Based on the Good Supply Practice(GSP),the defective items in the ″Quality Management System Documentation″ of pharmaceutical trading enterprises found in the supervision and inspection of Shandong Center for Food and Drug Evaluation&Inspection in 2023 were analyzed,summarized the management status,and put forward relevant regulatory suggestions.Results This unit carried out 280 times of supervision and inspection of pharmaceutical trading enterprises,including four types of on-site inspections:compliance inspection,key inspection,special inspection and cause-based inspection.A total of 2 201 defective items were identified,among which the number of defective items in the ″Quality Management System Documentation″ was the largest(398 items,18.08%),which contained 21 clauses,including no serious defect,7 major defects(121 items,30.40%)and 13 general defects(277 items,69.60%).The main defects included non-standard implementation,incomplete system coverage,incomplete formulation of department and post responsibilities or inadequate performance of duties,lack of operability of operation procedures in each operation link,and non-compliance of record management in each link of drug operation process.The general defects included non-standard labeling,unclear text expression,non-regular review and revision,failure to timely clean up invalid documents,lack of necessary documents for posts,lax management of computer system record data,and non-standard changes in written records.Conclusion There are still many deficiencies in the formulation,management and practical application of quality management system documentation among pharmaceutical trading enterprises in Shandong Province.These enterprises need to further strengthen their internal quality management awareness,and drug regulatory authorities need to strengthen publicity and guidance.It is suggested that pharmaceutical trading enterprises should enhance the sense of main responsibility,improve the construction of quality management system documentation,and strengthen training to improve the professional ability of staff in various positions.关键词
药品经营企业/质量管理体系文件/缺陷项目/药事管理/药品经营质量管理规范/山东省Key words
pharmaceutical trading enterprise/quality management system documentation/defective item/pharmacy administration/Good Supply Practice/Shandong province分类
医药卫生
