A制药有限公司质量管理体系研究

发布时间：2018-05-20 13:45

本文选题：GMP + 全面质量管理　；参考：《云南财经大学》2016年硕士论文

【摘要】：任何一家谋求发展的制药企业都需要思考这样一个问题“如何有效的保障药品质量”。药品的作用是预防、治疗人的疾病,有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质。作为一种特殊的商品,药品的质量直接关系到人们的健康和安全。近几年的黑龙江省完达山刺五加事件导致3人死亡,“毒胶囊”在社会中引发的药品质量风波,中央电视台披露的“药用胶囊厂用皮革废料生产明胶做原料”,以及新闻媒体曝光国内9家制药企业的13种产品采用了铬超标的空心胶囊等事件,表明了药品安全方面还存在很多问题,重要的是这些问题直接对人民的健康和生命造成了重大威胁。此外,药品质量还关乎制药企业的生存死亡,中小型制药企业更是如此。药品质量的关键是确立质量管理的战略地位,通过全员参与和长期坚持,不断完善和持续改进企业质量管理体系。不断引入新的管理理念改进质量管理体系对于提升企业内部管理、提高企业产品的质量、增强企业的市场竞争力等都具有重要意义。目前一些中小制药企业尚未建立系统、高效、全产业链的质量管理体系,一些已经通过GMP认证的制药企业的质量管理体系还存在一定的误区和盲区。因此,开展制药企业尤其是中小制药企业质量管理体系研究,探讨中小制药企业全面质量管理体系建设,以确保我国药品安全非常必要且具有重要现实意义。本文系统分析了A制药有限公司发展现状及质量管理中存在的问题,全面分析公司在建立质量管理体系方面的优势和劣势,以及公司面临的机遇和威胁,深入探索了该公司质量管理问题产生的原因。同时结合A制药有限公司实际情况,借鉴全面质量管理理论,从战略选择角度分别提出A制药有限公司GMP运行管理改进措施。一是将全面质量管理和GMP理念融入企业文化建设,塑造企业文化,打造企业品牌。二是通过生产设备更新达到简化生产程序、优化生产工艺的目的。三是加强员工技能培训,制定优质高效的培训方案,充分体现“全员参与”、“全过程参与”和“全面参与”,强化个人责任与产品质量的联系。希望通过本文的研究给其他中小型制药企业提供借鉴与帮助。
[Abstract]:Any pharmaceutical company seeking development needs to think about how to ensure drug quality effectively. The role of drugs is to prevent, treat human diseases, purposefully regulate human physiological function and specify indications or functional treatment, usage and dosage of substances. As a special commodity, the quality of medicine is directly related to people's health and safety. In recent years, the incident of Acanthopanax senticosus in Wanda Mountain, Heilongjiang Province, resulted in the death of three people. The "toxic capsule" caused a disturbance in the quality of drugs in society. "the medicinal capsule factory uses leather waste to produce gelatin as raw material," according to CCTV. As well as the news media exposure of 13 kinds of products of 9 domestic pharmaceutical enterprises using hollow capsules with chromium exceeding the standard, this shows that there are still many problems in drug safety. It is important that these problems pose a direct threat to the health and life of the people. In addition, drug quality also relates to the survival and death of pharmaceutical enterprises, especially small and medium-sized pharmaceutical enterprises. The key of drug quality is to establish the strategic position of quality management and improve the enterprise quality management system continuously through the participation of all personnel and long-term persistence. The introduction of new management concepts to improve the quality management system is of great significance for improving the internal management of enterprises, improving the quality of enterprise products and enhancing the market competitiveness of enterprises. At present, some small and medium-sized pharmaceutical enterprises have not established a system, high efficiency, whole industry chain quality management system, some pharmaceutical enterprises that have passed the GMP certification quality management system still has certain misunderstanding and blind zone. Therefore, it is necessary and important to study the quality management system of pharmaceutical enterprises, especially small and medium-sized pharmaceutical enterprises, and to explore the construction of total quality management system of small and medium-sized pharmaceutical enterprises in order to ensure drug safety in China. This paper systematically analyzes the present situation of A Pharmaceutical Co., Ltd and the problems existing in the quality management, analyzes the strengths and weaknesses of the company in establishing the quality management system, and the opportunities and threats faced by the company. The causes of the quality management problems of the company are explored in depth. At the same time, combined with the actual situation of A Pharmaceutical Co., Ltd and referring to the theory of Total quality Management, the improvement measures of GMP operation management in A Pharmaceutical Co., Ltd were put forward from the angle of strategic choice. First, the concept of total quality management and GMP into the construction of corporate culture, shaping corporate culture, building enterprise brand. The second is to simplify the production process and optimize the production process by updating the production equipment. The third is to strengthen the training of staff skills, formulate high-quality and efficient training programs, fully reflect the "full participation", "whole process participation" and "overall participation", and strengthen the relationship between personal responsibility and product quality. Hope to provide reference and help to other small and medium-sized pharmaceutical enterprises through the research of this paper.
【学位授予单位】：云南财经大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：F426.72;F273.2

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