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
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篇名: 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
TITLE:
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 reference for the sustainable development of pharmaceutical enterprises in Guizhou province. METHODS: A questionnaire was conducted for 55 pharmaceutical enterprises in Guizhou province, the basic situation of enterprises, familiarity of related directors to Good Manufacture Practice of Drugs (GMP) and relevant policy, the current situation of implementing the new version GMP were investigated and statistically analyzed, problems were found, and corresponding countermeasures were put forward. RESULTS & CONCLUSIONS: Totally 55 questionnaires were sent out, 49 valid ones were received with effectively recovery of 85.1%. The results showed 43 enterprises (87.8%) had passed the GMP authentication; only 13 enterprises (26.5%) directors were very familiar with the new version GMP. In terms of personnel management, the head of production management and quality management and the authorized person of quality and personnel had not yet met related requirements of the new version GMP fully; in terms of equipment and production management, production area transformation (clean areas, lounges, warehouses, water use) and air purification system design in most enterprises met related requirements of the new version GMP, 23 enterprises (46.9%) still can not conduct fully inspection to products and materials; in terms of document management, there were still some enterprises not meeting the new version GMP standards fully, enterprises’ documents (health area layout, air purification layout, management procedures, operating procedures, etc.) of production site were imperfect. According to the investigation, the main existing problems included lack of funds in implementing the new version GMP reform, not enough understanding or familiarity with the new version GMP, relevant personnel management not reaching the designated position, equipment and production management needing to be strengthened, document management systemic being poor, risk management being not sound, etc. It is suggested that government should give all forms of capital policy and strengthen the training of the new version GMP; enterprises should attach great importance to the relevant personnel management, strengthen the equipment and production management, set up perfect document management system and a sound system of risk management.
期刊: 2017年第28卷第7期
作者: 周戈耀,陈文佼,田海玉,孟小夏,程佳
AUTHORS: ZHOU Geyao,CHEN Wenjiao,TIAN Haiyu,MENG Xiaoxia,CHENG Jia
关键字: 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
KEYWORDS: Pharmaceutical enterprise; New version; Good manufacture practice of drugs; Current implementation situation; Guizhou province
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