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论文编号：	12879
作者编号：	2320190405
上传时间：	2021/12/13 12:53:37
中文题目：	KY药业医药建设项目管理优化研究
英文题目：	Management Improve Study for KY Pharmaceutical Co. Ltd Relocation Project
指导老师：	杨坤
中文关键字：	制药企业；项目管理；医药建设项目；管理；优化
英文关键字：	Pharmaceutical Industry； Project Management；Pharmaceutical Construction Projects；Management；Mindset; Optimize；
中文摘要：	十三五期间医药行业发展整体面临重大变革，随着仿制药品一致性评价的稳步推进，新药品管理法的落地实施，药品上市许可持有人制度的推行，我国仿制药质量水平得到系统性提升，药品生产、质量管理日趋规范。未来五年，十四五规划的逐步实施，医药行业将迎来重大变革，未来我国药品生产、质量管理会逐步向规范市场看齐，国家药品监督管理局对制药企业的监管形势会更加严格，制药企业通常采用对现有厂房设施进行改造、扩建或异地迁建（以下统称医药建设项目）的方式应对不断提升的行业标准，满足产能扩张、生产效率、产品质量方面的要求，解决在通过仿制药品一致性评价改变生产工艺后带来的问题。在此背景下，天津KY药业有限公司为满足生产及质量的需要，开展了新厂建设项目，但是由于医药建设项目的特殊性，项目在开展实施过程中状况不断，最终导致项目无法按计划顺利完成，针对天津KY药业医药建设项目现状，本文从探究KY药业医药建设项目无法顺利完成的原因入手，对如何解决项目中存在的问题，优化KY药业医药建设项目管理展开了研究。 本文基于项目管理相关理论，采用文献回顾、对行业内人员访谈的方式，对天津KY药业医药建设项目进行了研究和探讨，找出该项目在规划、实施过程中存在的问题，探寻产生问题的根本原因，并提出相应的解决方案，优化天津KY药业医药建设项目，同时本文试图通过对该项目的优化研究，为国内相似医药建设项目提供理论研究基础，找出医药建设项目所有者应关注的重点内容，让项目参与者对医药建设项目有共同的理念，探索出适合我国医药建设项目的组织管理方法，从而提高我国制药企业组织管理医药建设项目的水平，优化我国医药建设项目管理。
英文摘要：	During the national 13th Five-Year Plan, the overall development of the pharmaceutical industry is facing major changes. With the steady advancement of the consistency evaluation of generic drugs, the implementation of the new drug management law, and the implementation of the drug marketing authorization holder system, the quality of our country's generic drugs has been improved systematically, Drug production and quality management are becoming more and more standardized. In the next five years, with the gradual implementation of the national 14th Five-Year Plan, the pharmaceutical industry will usher in major changes. In the future, our country’s pharmaceutical production and quality management will gradually follow the normative market, and the National Medical Products Administration’s(NMPA) supervision of pharmaceutical companies will become more stringent. Pharmaceutical companies usually adopt the method of transformation, expansion or reconstruction of existing plant facilities (hereinafter collectively referred to as pharmaceutical construction projects) to respond to rising industry standards, meet capacity, production efficiency and product quality requirements, and resolve changes follow consistency evaluation of generic drugs. problems in the production process. In this context, Tianjin Kaiyong Pharmaceutical Co., Ltd. launched a new plant construction project in order to meet the needs of production and quality. However, due to the particularity of the pharmaceutical construction project, the unexpected problems occurred continued during the implementation process, which ultimately led to the failure of the project. In view of the current status of Tianjin Kaiyong pharmaceutical construction project, as lesson and learn, this article try to find out starts with exploring the root causes why the Kaiyong pharmaceutical construction project could not be completed successfully, and how to solve the problems in the project and optimize the management of Kaiyong pharmaceutical construction project If it could start from beginning again. Based on the related theories of project management, this thesis uses literature review and interviews with people in the Kaiyong project to research and discuss the pharmaceutical construction project of Tianjin Kaiyong Pharmaceutical, find out the problems in the strategic planning and implementation phases of the project. The root cause and corresponding solutions are proposed to optimize the medical construction project of Tianjin Kaiyong Pharmaceutical. At the same time, this article attempts to provide a theoretical research foundation for similar medical construction projects in China through the optimization study of the project, and to find out what the owner of the medical construction project should be. Focus on the key content, let the project participants have a mindset and common goal about the pharmaceutical construction project, explore the organization and management method suitable for China's pharmaceutical construction project, so as to improve the level of China's pharmaceutical enterprises to organize and manage pharmaceutical construction projects, and optimize the management of China's pharmaceutical construction projects.
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