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本文通过对上海市高风险药品生产企业的问卷调查,对部分企业走访调研收集相关资料,通过统计分析,从偏差发生概况、偏差管理制度、偏差管理的部门与人员、偏差管理系统与其他管理系统的关联、偏差管理实践与难点等五个方面呈现了偏差管理的现状。对生产企业的管理水平与偏差发生概率及产品特性与偏差发生概率进行了关联度检验,显示目前的状态下,没有呈现出相关性。运用案例分析,对企业目前在偏差管理实践中的不足与缺陷进行了剖析。从国内外监管法规比较得出对于偏差管理的规定集中在于文件规定、记录、调查、人员职责、放行、纠正与预防等方面。根据现状与法规要求,从实施行政监管检查、督促企业自我完善、客观对待偏差现象、形成能力评估体系、适时开展培训交流等五个方面提出监管对策建议。
Based on the questionnaire survey of Shanghai high-risk drug manufacturers, this paper collects relevant data from some enterprises to visit and investigate, through statistical analysis, from the deviation occurrence, deviation management system, deviation management department and personnel, deviation management system and other management systems The relationship between deviation management practices and difficulties in five aspects of deviation management status quo. The level of management of production enterprises and the probability of occurrence of deviation and product characteristics and the probability of occurrence of bias correlation test, indicating that the current state, did not show the relevance. Using the case analysis, the author analyzes the shortcomings and defects of the enterprise in deviation management practice at present. According to the comparison between domestic and foreign regulatory laws and regulations, the provisions on deviation management focus on document regulation, records, investigation, personnel duties, release, correction and prevention. According to the status quo and the requirements of laws and regulations, the paper proposes regulatory measures from the following five aspects: implementing administrative supervision and inspection, supervising enterprises to self-improve, objectively treating deviation phenomena, forming capacity assessment system and timely training exchange.