| 2014-2018年安徽省中药饮片生产企业执行药品生产质量管理规范检查的缺陷分析 |
| 投稿时间：2021-01-08 修订日期：2021-03-01 点此下载全文 |
| 引用本文：尹鹏军,胡士高.2014-2018年安徽省中药饮片生产企业执行药品生产质量管理规范检查的缺陷分析[J].药学实践杂志,2021,39(3):287~290 |
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| 中文摘要:目的 为提高中药饮片生产质量管理提出改进措施与建议，为中药饮片生产监管提供思路与对策。方法 采用回顾性统计分析方法，对2014-2018年安徽省50家未通过药品生产质量管理规范（GMP）认证的中药饮片生产企业检查发现的严重缺陷及主要缺陷项目进行分析。结果 未通过GMP认证的中药饮片生产企业存在的主要问题集中在企业法人或者负责人法律意识淡薄，关键人员履职能力不足，生产记录或者检验原始数据不能追溯，物料管理混乱，生产管理系统或者质量控制系统不能有效运行等方面。结论 建议中药饮片生产企业应提高法律意识，加强诚信建设，注重人员培训，严格规范生产；监管部门应突出专业性和职业化，切实保证中药饮片质量安全。 |
| 中文关键词:中药饮片 药品生产质量管理规范 检查 缺陷 |
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| GMP Defects in the field inspection for processed Chinese herbal medicine manufacturers in Anhui Province during 2014 to 2018 |
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| Abstract:Objective To propose the improvement measures and suggestions for the better quality management of processed Chinese herbal medicine production and provide insights and solutions for the quality control of processed Chinese herbal medicine production.Methods A retrospective statistical analysis was used to analyze the serious defects and major defects found in 50 processed Chinese herbal medicine manufacturers that failed to pass GMP certification in Anhui province from 2014 to 2018.Results The main problems found in processed Chinese herbal medicine manufacturers that failed to pass GMP certification were the low law consciousness of the legal representative or responsibility person, poor performance of key personnel, untraceable original data of the production records or testing, orderless material managements, ineffective operation of the manufacturing management system or quality control system.Conclusion It is recommended that processed Chinese herbal medicine manufacturers should enhance legal awareness, build good faith, pay attention to personnel training and GMP compliance. The regulatory authority should exercise the professionalism to ensure the quality and reliability of processed Chinese herbal medicines. |
| keywords:Processed Chinese herbal medicine good manufacturing practice inspection defects |
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