全面质量管理在MG医药企业生物制药项目中的应用

发布时间：2018-02-23 21:21

本文关键词： 全面质量管理质量文化药品质量持续改进　出处：《吉林大学》2017年硕士论文　论文类型：学位论文

【摘要】：随着经济的发展与人们生活水平的日益提高,药品的质量安全越来越备受关注,加强对药品生产质量的管理,不仅维护了用药人的合法权益及生命安全与健康,也将为企业赢得客户的尊重与信任,使企业得以长久、稳定的发展起着至关重要的作用。在国内,包括生物技术公司在内的6000多家制药企业普遍存在自我创新能力低、研发投入不足及产品质量堪忧等问题。而全面质量管理模式已在国内外优秀企业中被广泛推广,并形成了作用较为显著的全面质量管理方法。众多的实例证明,实施全面质量管理确实能够在提高产品质量、降低生产成本、提高生产效率以及赢得客户满意等方面起到积极的作用。MG医药企业创建于1985年,经历30年的创业和发展,相继研制开发了中药品牌和众多生物注射剂,以及葡萄酒、环保建材等一系列名优产品。企业自成立以来,为使企业逐步做大做强,一直秉承着“质量重于一切,要干就是一流”的管理理念,很早便引进先进的质量管理模式对企业质量管理的综合性、整体性进行提升,从而达到提高产品质量、提高客户满意度、增强企业核心竞争力的总体要求,使企业得以长远、稳定、健康可持续发展。本文运用文献查阅法、调查研究法、案例分析法、PDCA循环法等方法,通过前期资料的大量搜集和反复论证,提出了MG医药企业生物制药项目实施全面质量管理对企业发展具有十分重要的意义,并详细分析了企业的质量管理现状及出现的问题,并用理论与生物制药生产管理模式相结合的方式,对质量管理问题进行了评估,从而进一步优化企业的质量管理体系,改进质量管理策略与现行的模式,提出相应的解决措施,并对改进后的质量管理体系应用于实践之中的效果进行经验总结,发现问题再进行改进,从而使产品质量达到最优化,增强企业抵御市场风险的能力,确保MG医药企业在持续、健康的状态下发展,同时也通过本文为国内外其他医药企业的质量管理提供一定的借鉴。虽然通过本文坚实的理论基础和详细的调查、分析和改进,MG医药企业已经成功构建出了符合企业长远发展的新的全面质量管理体系,也取得了一定的成效,但是仍存在着一些不足之处。在今后的工作和学习中,还要通过大量阅读文献资料和对MG医药企业持续跟踪与关注,从而找出企业运用新的质量管理体系中存在的问题进行修订与完善,得出更加符合企业实际的研究成果。
[Abstract]:With the development of economy and the improvement of people's living standard, more and more attention has been paid to the quality and safety of drugs. Strengthening the management of drug production quality not only maintains the legitimate rights and interests of drug users, but also the safety and health of their lives. It will also win the customer's respect and trust for the enterprise, and make the enterprise develop for a long time and steadily. In China, more than 6,000 pharmaceutical enterprises, including biotechnology companies, have low self-innovation ability. The research and development investment is insufficient and the product quality is worrisome. However, the total quality management model has been widely popularized in the excellent enterprises at home and abroad, and has formed a more significant total quality management method. The implementation of TQM can indeed play a positive role in improving product quality, reducing production costs, improving production efficiency and winning customer satisfaction. The pharmaceutical enterprise of MG was founded in 1985 and has experienced 30 years of entrepreneurship and development. We have developed and developed traditional Chinese medicine brands and many biological injections, as well as a series of famous and excellent products such as wine, environmental protection building materials and so on. Since the establishment of the enterprise, in order to make the enterprise bigger and stronger, it has been adhering to "quality is more important than anything," If we want to do this, it is the first class management concept. The advanced quality management model has been introduced very early to enhance the comprehensiveness and integrity of enterprise quality management, so as to improve the quality of products and improve customer satisfaction. In order to enhance the overall requirements of the core competence of enterprises, enterprises can develop in a long-term, stable and healthy and sustainable manner. In this paper, the methods of literature review, investigation and research, case analysis and PDCA cycle method are used in this paper. Through a large amount of data collection and repeated argumentation, this paper points out that the implementation of TQM in MG pharmaceutical enterprises is of great significance to the development of enterprises, and analyzes in detail the present situation and problems of quality management in MG pharmaceutical enterprises. By combining the theory with the production management mode of biopharmaceuticals, the quality management problems are evaluated, so as to further optimize the quality management system of the enterprise, improve the quality management strategy and the current mode, and put forward the corresponding solutions. The effect of the improved quality management system applied in practice is summarized and the problems are found to be further improved so that the product quality can be optimized and the ability of the enterprise to resist the market risks can be enhanced to ensure that the MG pharmaceutical enterprises are continuing. Development in a healthy state, but also through this article to provide some reference for the quality management of other pharmaceutical enterprises at home and abroad, although through the solid theoretical basis of this article and detailed investigation, The analysis and improvement of the pharmaceutical enterprises of MG have successfully constructed a new total quality management system which accords with the long-term development of the enterprises, and has also achieved certain results, but there are still some shortcomings in the future work and study. In order to find out the problems existing in the application of the new quality management system in order to correct and perfect the research results which are more in line with the actual situation of the enterprises, we should read a lot of literature and follow up and pay close attention to the MG pharmaceutical enterprises continuously in order to find out the problems existing in the application of the new quality management system.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F426.72;F273.2

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