X公司药品生产中的热原控制及改善研究
发布时间：2018-10-12 09:36
【摘要】：近年来,随着人们对于医疗卫生事业的重视以及国家对于药品生产监管力度的逐渐加强,越来越多的药品生产质量问题被重视起来。药品生产的过程以及最终产品管理中有很多控制因素,热原在药品生产过程中是必须加以控制的,也是药品质量检验的重要项目之一。在项目管理领域中,项目质量管理是为了确保项目达到客户所规定的质量要求所实施的一系列的管理过程。本文以一种被广泛地应用于医药与化妆品等行业的药品T产品为例,研究和分析其质量管理中对于热原控制的影响因素,以提高和改善热原的控制管理水平,从而提高产品质量,增强产品的市场竞争力。本文首先阐述药品中热原问题的背景,然后通过鱼骨图和风险分析法等工具得出了药品中可能产生的途径和原因。在整体项目中通过运用领导、组织、用人、计划和控制几个因素,实现了对于产品的质量规划、质量控制和质量保证。从某市X公司生产T产品的药品生产的全过程出发,针对生产过程特性、工艺特性等原因进行分析,深入探讨优化改善热原控制的方案,并且结合产品微生物菌种发酵和吸附过滤工艺的特点,以发酵菌种、发酵pH、吸附过滤工艺为关键控制指标,寻求过程控制与产品质量合格之间的关系。最终通过工艺参数优化和工艺改进的研究,提出药品生产中热原控制和质量改善的解决方案。在解决问题的过程中,通过成立项目组,运用相关的项目管理理论并结合产品的实际结果进行总结、讨论、原因分析和改进方案制定。通过此项目的研究,能够提升药品生产中的热原质量控制,同时提高公司产品的市场竞争力。
[Abstract]:In recent years, with the attention of people to medical and health care and the strengthening of national supervision on drug production, more and more problems of drug production quality have been paid attention to. There are many controlling factors in the process of drug production and final product management. Pyrogen must be controlled in the process of drug production, and it is also one of the important items of drug quality inspection. In the field of project management, project quality management is a series of management processes to ensure that the project meets the quality requirements set by the customer. Taking a pharmaceutical T product widely used in pharmaceutical and cosmetic industries as an example, this paper studies and analyzes the factors affecting pyrogen control in its quality management, in order to improve and improve the level of pyrogen control and management. In order to improve product quality, enhance the market competitiveness of products. In this paper, the background of pyrogen problem in drugs is introduced, and then the possible ways and causes of drug production are obtained by means of fish bone map and risk analysis. In the overall project through the use of leadership, organization, personnel, planning and control of several factors to achieve the quality of the product planning, quality control and quality assurance. Starting from the whole process of the production of T products in a certain city X Company, the characteristics of the production process and the process characteristics are analyzed, and the scheme of optimizing and improving the pyrogen control is discussed in depth. According to the characteristics of microbial fermentation and adsorption filtration process, the key control index is fermentation strain and fermentation pH, adsorption filtration process, and the relationship between process control and product quality qualification is sought. Finally, through the research of process parameter optimization and process improvement, the solution of pyrogen control and quality improvement in pharmaceutical production is put forward. In the process of solving the problem, the project team is set up, and the relevant project management theory is used to sum up, discuss, analyze and improve the project. Through the research of this project, the quality control of pyrogen in pharmaceutical production can be improved, and the market competitiveness of the company's products can be improved.
【学位授予单位】：天津大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.72
本文编号：2265643
[Abstract]:In recent years, with the attention of people to medical and health care and the strengthening of national supervision on drug production, more and more problems of drug production quality have been paid attention to. There are many controlling factors in the process of drug production and final product management. Pyrogen must be controlled in the process of drug production, and it is also one of the important items of drug quality inspection. In the field of project management, project quality management is a series of management processes to ensure that the project meets the quality requirements set by the customer. Taking a pharmaceutical T product widely used in pharmaceutical and cosmetic industries as an example, this paper studies and analyzes the factors affecting pyrogen control in its quality management, in order to improve and improve the level of pyrogen control and management. In order to improve product quality, enhance the market competitiveness of products. In this paper, the background of pyrogen problem in drugs is introduced, and then the possible ways and causes of drug production are obtained by means of fish bone map and risk analysis. In the overall project through the use of leadership, organization, personnel, planning and control of several factors to achieve the quality of the product planning, quality control and quality assurance. Starting from the whole process of the production of T products in a certain city X Company, the characteristics of the production process and the process characteristics are analyzed, and the scheme of optimizing and improving the pyrogen control is discussed in depth. According to the characteristics of microbial fermentation and adsorption filtration process, the key control index is fermentation strain and fermentation pH, adsorption filtration process, and the relationship between process control and product quality qualification is sought. Finally, through the research of process parameter optimization and process improvement, the solution of pyrogen control and quality improvement in pharmaceutical production is put forward. In the process of solving the problem, the project team is set up, and the relevant project management theory is used to sum up, discuss, analyze and improve the project. Through the research of this project, the quality control of pyrogen in pharmaceutical production can be improved, and the market competitiveness of the company's products can be improved.
【学位授予单位】：天津大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.72
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