SJZ药业公司药品生产质量管理研究

发布时间：2018-05-13 22:35

  本文选题：GMP + 质量管理程序问题分析和改善　； 参考：《河北经贸大学》2017年硕士论文

【摘要】：本文以SJZ药业公司为研究对象,该公司从2010年至今多次通过欧盟认证和美国FDA认证,整个质量管理体系符合欧盟和美国CGMP的要求,但是我们在质量管理的几个关键程序的日常运行过程中仍然发现不少的问题,比如变更管理,偏差管理,人员培训管理,还有供应商管理等方面的问题。本文主要采用风险管理的工具对每一个问题进行详细具体地分析,从而找出影响该管理程序的根源问题。变更管理不够完善,管理效果不太理想,变更控制缺乏有效的指导;由于人员,设备,物料等原因导致的偏差;由于人员的培训管理不到位导致各种问题;还有供应商的管理过程中出现的问题。通过对这些管理程序进行风险分析,找到根本影响因素,并且针对根本影响因素制定有效的纠正预防措施,并付诸实施,总结实施效果和经验,得出本论文的研究结论。第一、通过改善变更管理程序,对于所有变更,在现有欧美药品法规和指南的指导下,制定有效可行的行动方案;各部门协调配合执行,各部门共同参与讨论和决策。第二、通过改善偏差管理程序,有效降低了偏差发生频率,减少物料损失和延长工期的事件发生率。第三、通过建立严格的人员培训制度并严格执行,同时建立严格的考核制度,提高大家的责任感,降低了因人员误差导致偏查的发生率。第四、通过改善供应商管理程序,加强了对供应商的管理,有效降低原辅料质量问题的发生率,充分保证原辅料的质量。通过对这几项管理程序改善,提高了质量管理水平和管理能力,从而更加有效的管理变更、减少偏差的发生、提高人员培训的效果、提高对供应商的管理水平,充分保障原辅料的质量,从根源上杜绝质量安全隐患;使该公司的质量管理水平上升一个全新的高度,充分保证产品的质量,维护好公司良好的品牌价值形象。
[Abstract]:This paper takes SJZ Pharmaceutical Company as the research object, the company has passed the European Union certification and the United States FDA certification many times since 2010, the entire quality management system conforms to the European Union and the United States CGMP request, the entire quality management system conforms to the European Union and the American CGMP request, However, we still find many problems in the daily operation of several key procedures of quality management, such as change management, deviation management, personnel training management, and supplier management. In this paper, we use risk management tools to analyze each problem in detail, and find out the root problem that affects the management program. The change management is not perfect, the management effect is not very ideal, the change control lacks the effective guidance; because of the personnel, the equipment, the material causes the deviation, because the personnel training management is not in place causes each kind of question; There are also problems in the management of suppliers. Through the risk analysis of these management procedures, find out the fundamental factors, and make effective corrective and preventive measures against the fundamental factors, and put them into practice, summarize the implementation effect and experience, and draw the conclusion of this paper. First, through the improvement of change management procedures, for all changes, under the guidance of existing European and American drug regulations and guidelines, to formulate effective and feasible action plan; all departments coordinate the implementation, and all departments participate in discussions and decisions. Secondly, by improving the deviation management program, the frequency of deviation is reduced effectively, the loss of materials and the occurrence rate of extended period are reduced. Thirdly, through the establishment of strict personnel training system and strict implementation, at the same time, the establishment of strict assessment system, improve the sense of responsibility of everyone, and reduce the incidence of personnel errors caused by biased investigation. Fourth, by improving the supplier management procedures, the management of suppliers has been strengthened, and the occurrence rate of quality problems of raw and auxiliary materials has been effectively reduced, and the quality of raw and auxiliary materials has been fully guaranteed. Through the improvement of these management procedures, the quality management level and management ability are improved, thus more effective management changes, reduce the occurrence of deviation, improve the effect of personnel training, improve the management level of suppliers, The quality of raw and auxiliary materials is fully guaranteed, the hidden dangers of quality and safety are eliminated from the root, the quality management level of the company is raised to a new height, the quality of products is fully guaranteed, and the good brand value image of the company is maintained.
【学位授予单位】：河北经贸大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F426.72;F273.2
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本文编号：1885141