贵州省医药生产企业施行新版《药品生产质量管理规范》的现状研究

发布时间：2018-02-23 17:04

本文关键词： 医药生产企业新版药品生产质量管理规范实施现状贵州省　出处：《中国药房》2017年07期 　论文类型：期刊论文

【摘要】：目的:为贵州省医药生产企业可持续发展提供参考。方法:选择贵州省55家医药生产企业开展问卷调查,对企业基本情况、相关负责人对《药品生产质量管理规范》(GMP)及相关政策的熟悉程度、实施新版GMP的现状等进行调查并进行统计分析,发现问题并提出相应对策。结果与结论:共发放问卷55份,回收有效问卷49份,问卷回收率为89.1%。统计结果显示,43家企业(87.8%)通过了GMP认证;仅13家企业(26.5%)负责人表示对新版GMP非常熟悉。在人员管理方面,生产管理负责人、质量管理负责人、质量授权人尚未完全达到新版GMP的相关要求;在设备及生产管理方面,多数企业的生产区相关改造(如洁净区、休息室、库房、用水等)、空气净化系统设计符合新版GMP要求,23家企业(46.9%)尚不能对产品和物料进行全面检验;在文件管理方面,部分企业没有完全达到新版GMP的标准,生产作业现场文件(包括卫生区域布局图、空气净化布局图、管理规程、操作规程等)不完善。调查中发现各企业普遍存在施行新版GMP改造资金缺乏、对新版GMP的了解程度或熟悉程度不够、相关人员管理不到位、设备及生产管理较弱、文件管理系统性差、风险管理不健全等问题。建议政府应实施相应资金扶持政策,组织加强对新版GMP的培训;企业应重视相关人员管理、强化设备及生产管理、建立完善的文件管理系统和健全风险管理体系。
[Abstract]:Objective: to provide a reference for the sustainable development of pharmaceutical production enterprises in Guizhou Province. The responsible persons concerned investigated and statistically analyzed the familiarity with the Drug production quality Management Standard and related policies, the status quo of implementing the new version of GMP, found problems and put forward corresponding countermeasures. Results and conclusions: a total of 55 questionnaires were sent out. The statistical results show that 43 enterprises (87.8%) have passed the GMP certification; only 13 enterprises (26.5%) have said that they are very familiar with the new version of GMP. In terms of personnel management, the responsible person of production management, The responsible person in charge of quality management, the quality authorized person has not fully met the relevant requirements of the new version of GMP; in terms of equipment and production management, most enterprises' production area is related to the transformation (such as clean area, lounge room, storeroom, etc.). The air purification system is designed to meet the requirements of the new version of GMP, and 23 enterprises (46.9) have not yet been able to carry out a comprehensive inspection of products and materials; in terms of document management, some enterprises have not fully met the standards of the new version of GMP. The production site documents (including sanitary area layout map, air purification layout map, management rules, operation rules, etc.) are not perfect. The new version of GMP is not well understood or familiar enough, the related personnel management is not in place, the equipment and production management is weak, the document management system is poor, the risk management is not perfect and so on. It is suggested that the government should implement the corresponding fund support policy. The organization should strengthen the training of the new version of GMP, the enterprise should pay attention to the personnel management, strengthen the equipment and production management, establish a perfect document management system and perfect risk management system.
【作者单位】：贵州医科大学医药卫生管理学院;
【基金】：贵州省教育厅高校人文社会科学研究硕士点项目(No.14SSD003)
【分类号】：R95

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