电子监管下药品生产管理研究

发布时间：2018-01-20 00:53

本文关键词： 药品生产管理电子监管信息化　出处：《北京交通大学》2013年硕士论文　论文类型：学位论文

【摘要】：本文通过综合利用药品生产管理理论、信息化管理理论和系统理论,并结合个人多年从事药品生产质量管理的经验,对实施电子监管码为主要方式的国家药品电子监管模式下的药品生产管理进行研究。研究中运用药品生产质量管理理论研究药品生产管理的要点内容,运用信息化管理相关理论研究药品电子监管条件下实施药品生产管理的重要方式,运用系统理论为指导研究药品电子监管条件下药品生产管理的管理策略。并通过大型跨国制药企业的中国子公司A公司的具体实例,进一步说明这一药品生产管理策略的内容和具体运用。通过分析研究,论文得出如下结论：电子监管条件下建议国内药品生产企业运用以下管理策略进行药品生产管理：以电子批记录和建立完善的生产信息系统的方式,重点管理生产过程中的关键环节、关键工艺参数和生产工艺的整个生命周期和做好生产中的变更、偏差和纠正预防措施管理。同时,进行生产管理还要从企业目标层面,借助信息管理系统的优势,完善生产质量自我电子监管的功能,最终建立一个以生产为核心,既可以实现企业内部药品生产质量自我监管,又可以对接国家电子监管网络,能够密切配合监管部门并及时反馈相关信息,可以实现体现高水平药品生产管理理念的企业级生产管理信息系统。同时,也在加强企业生产成本管理和企业品牌管理方面发挥重要作用。
[Abstract]:Through the comprehensive use of drug production management theory, information management theory and system theory, combined with personal experience in drug production quality management for many years. This paper studies the drug production and management under the mode of electronic supervision of national drugs with electronic regulatory code as the main mode. In the study, the main content of drug production management is studied by using the theory of drug production quality management, and the important way of implementing drug production management under the condition of electronic supervision of drugs is studied by using the relevant theory of information management. The system theory is used to study the management strategy of drug production management under the condition of electronic drug supervision, and through the specific examples of A Company, a subsidiary of large multinational pharmaceutical enterprises. Further explain the content and application of this drug production management strategy. Through analysis. The conclusion is as follows: under the condition of electronic supervision, it is suggested that domestic drug manufacturing enterprises should use the following management strategies: electronic batch recording and the establishment of a perfect production information system. Focus on the key links in the production process, key process parameters and the entire life cycle of the production process, and do well in the management of changes, deviations and corrective and preventive actions in production. To carry out production management, we should improve the function of self-electronic supervision of production quality with the help of the advantages of information management system, and finally establish a production as the core. It can not only realize the self-supervision of the internal drug production quality, but also connect with the national electronic regulatory network, which can cooperate closely with the regulatory department and feedback the relevant information in time. It can realize the enterprise level production management information system which embodies the high level drug production management idea, at the same time, it also plays an important role in strengthening the enterprise production cost management and the enterprise brand management.
【学位授予单位】：北京交通大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F273;F426.72

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