山东省专营中药饮片批发企业许可缺陷及对策

Defective items and countermeasures of wholesale enterprises specialized in TCM decoction pieces in Shandong province

目的通过分析山东省专营中药饮片批发企业许可情况及现场检查发现的问题,提出对策与建议,为保障山东省中药质量提供参考。方法对2020—2022年山东省专营中药饮片批发企业许可检查的缺陷项目进行统计,分析存在的问题,并提出相应的对策。结果许可检查问题集中在质量管理体系文件、机构和质量管理职责、人员与培训、设施与设备方面。结论企业应严格落实主体责任,完善质量管理体系,重视内审工作,提高培训的实效性,转型升级,提高产业集中度。监管部门应强化监管,提高中药检查员现场检查能力,加快职业化、专业化的中药检查员队伍建设。

Objective The countermeasures and suggestions were put forward in order to provide reference for the guarantee of TCM quality in Shandong Province,through the analysis of the licensing situation and the problems found in the on-site inspection of the wholesale enterprises specialized in TCM decoction pieces in Shandong Province.Methods Statistics were made on defective items of licensing inspection of the wholesale enterprises specialized in TCM decoction pieces in Shandong Province from 2020 to 2022,the existing problems were analyzed to put forward countermeasures.Results The common problems found in the licensing on-site inspection mainly focus on quality management system documents,organization and quality management responsibilities,personnel and training,and facilities and equipment.Conclusion Enterprises should strictly implement the main responsibilities and improve the quality management system,pay attention to internal audit work and improve the effectiveness of training,should transform and upgrade to improve industrial concentration.The supervision department should strengthen supervision,improve the on-site inspection ability of TCM inspectors,and speed up the construction of professional and specialized TCM inspectors.