M制药公司药品质量监管体系建设项目管理

发布时间：2018-07-12 12:03

本文选题：制药公司 + 生产质量　；参考：《电子科技大学》2017年硕士论文

【摘要】：药品安全与人类的生命健康息息相关,药品的作用是治病救人,如果药品质量不合格,就可能会反过来威胁使用者的身体健康,甚至是生命安全。所以,国家非常重视药品生产的质量管理问题。2010年,我国药品食品管理局颁布了新一版的药品生产质量规范(以下简称GMP),新版GMP对1998年的旧版GMP进行了一些调整。为了保证药品生产质量标准与国际接轨,在此轮调整中,参考了一些美国和欧盟等国对药品生产质量的规范。因此,新版GMP对药品生产质量提出了更高的要求。药品食品管理要国内的制药企业必须严格按照新版GMP的要求开展药品生产管理工作,如果发现医药产品不符合新版GMP的要求,药品生产企业将会受到处罚,影响恶劣的甚至会被要求停业整顿,甚至于吊销医药生产资格证。新版GMP推行以后,国内医药生产企业叫苦不迭,认为新版GMP要求过于严格,但是医疗无小事,对医药质量高标准、严要求也是为了把好生产关,从源头上杜绝问题药品流入市场,这也是对广大人民群众负责。所以要求高并没有错,医药企业应该强化自身,提高药品生产管理水平,不断朝着新版GMP的标准靠近,生产出质量过硬的好药。正是在这样的背景下,制药公司开始加强对药品生产质量的重视。M制药公司由于被食品药品管理局的一次抽查查出药品质量不符合GMP标准并接受了处罚之后,痛定思痛,对现有的药品质量管理现状进行了重新审视,发现在药品生产质量管理方面存在诸多问题,所以便提出建立药品质量监管体系,以新版GMP作为药品生产质量的管理标准,全面致力于药品质量的提升。本文研究的正是M制药公司药品质量监督建设项目,将项目管理思想引入到M制药公司的生产质量监管体系建设之中,利用项目管理的目标思想,提升质量监管体系建设的执行力。本文着重分析项目实施之后存在的问题,对问题及时加以改进才能保证后续工作在项目计划内展开,才能保证最终达到项目对质量、成本和进度的要求。项目虽然具有周期性,但是药品质量提升却任重而道远,在这里可以将M公司的项目视为一个不断优化药品质量的循环,促进M制药公司药品质量管理体系上升到一个新的台阶。
[Abstract]:Drug safety is closely related to human life and health. The role of drugs is to cure diseases and save people. If the quality of drugs is not qualified, it may threaten the health of users, even the safety of life. Therefore, the state attaches great importance to the quality management of drug production. In 2010, China's Drug and Food Administration issued a new edition of the quality Standards for Drug production (hereinafter referred to as GMP), and the new version of GMP made some adjustments to the old version of GMP in 1998. In order to ensure that the quality standard of drug production is in line with the international standard, some countries, such as the United States and European Union, have been consulted in this round of adjustment on the quality of drug production. Therefore, the new GMP has put forward higher requirements to the quality of drug production. Drug and food management requires domestic pharmaceutical enterprises to carry out drug production management work strictly in accordance with the requirements of the new GMP. If they find that pharmaceutical products do not meet the requirements of the new GMP, drug manufacturing enterprises will be punished. Those with bad effects may even be required to close down and even revoke their pharmaceutical production qualifications. After the implementation of the new version of GMP, domestic pharmaceutical manufacturers have been complaining about it. They think that the new version of GMP is too strict, but the medical treatment is not trivial, and the high standard and strict requirements for the quality of medicine are also aimed at making production work well. From the source to stop the flow of problematic drugs into the market, this is responsible for the broad masses of the people. Therefore, there is no wrong with high demand, pharmaceutical enterprises should strengthen themselves, improve the level of drug production management, constantly close to the new GMP standards, and produce good medicine of excellent quality. It was against this background that pharmaceutical companies began to pay more attention to the quality of drug production. M Pharmaceutical Company learned from pain after a spot check by the Food and Drug Administration found that the quality of drugs did not meet GMP standards and was punished. This paper reviews the current situation of drug quality management, finds that there are many problems in drug production quality management, and puts forward the establishment of drug quality supervision system with the new edition of GMP as the management standard of drug production quality. We are fully committed to the improvement of drug quality. This paper studies the pharmaceutical quality supervision and construction project of M Pharmaceutical Company. The project management idea is introduced into the construction of production quality supervision system of M Pharmaceutical Company, and the goal of project management is used. Improve the implementation of quality supervision system construction. This paper focuses on the analysis of the problems existing after the implementation of the project, the timely improvement of the problems in order to ensure that the follow-up work is carried out in the project plan, and finally to meet the requirements of quality, cost and schedule of the project. Although the project has periodicity, but drug quality improvement is a long way to go, here we can regard M Company's project as a cycle of continuous optimization of drug quality. To promote M pharmaceutical company drug quality management system to a new level.
【学位授予单位】：电子科技大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F426.72;F273.2

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