药品批发企业质量管理体系运行中内审问题分析与对策研究

Analysis and Countermeasures of Internal Audit Problems in the Operation of Quality Management System in Pharmaceutical Wholesale Enterprises

目的:分析药品批发企业质量管理体系运行中存在的普遍问题,提出改善药品批发企业质量体系内审管理水平的具体实施建议,持续改进批发企业质量管理水平,控制药品经营环节风险,保证药品质量。方法:对328家药品批发企业GSP认证申报资料及现场检查报告中发现的企业内审工作中存在的具体问题进行汇总、整理、分析原因,发现当前企业普遍存在的问题,并探讨改进措施。结果与结论:药品批发企业应通过完善内审管理,建立完整严谨的标准和工作流程,强化企业内审工作的权威性和独立性,建立企业全员参与机制,提高内审人员的综合素质和能力;寻找质量管理体系文件贯彻执行的偏差;在体系关键要素发生重大变化或调整后,完善新经营环境下质量管理体系。从而确保企业在药品采购、储存、销售、运输等日常经营过程中均严格执行药品GSP,确保企业质量管理体系保持健康正常的运行。

Objective:To analyze the common problems in the operation of quality management system in pharmaceutical wholesale enterprises(PWEs),and to put forward concrete implementation proposals for improving the internal audit management level of quality system in PWEs,so as to continuously improve the quality management level of PWEs,control the risk of drug management and ensure the quality of drug.Methods:The specific problems in the internal audit of 328 PWEs found in the GSP certification application materials and on-site inspection reports were summarized,sorted out and analyzed.Subsequently,the common problems in PWEs were found out and the improvement measures were discussed.Results and Conclusion:The PWEs should establish the whole staff participation mechanism by perfecting the internal audit management,establishing the complete and strict standards and working procedures,strengthening the authority and independence of the internal audit work,to improve the comprehensive quality and ability of the internal auditors;to find out the deviation of the implementation of the quality management system documents;to make the quality system perfect under the new operating environment after the major changes or adjustments of the key elements of the system.Thus,it ensured that enterprises in drug procurement,storage,sales,transportation and other daily business processes strictly implemented GSP,and well maintained the enterprise quality management system.