近年来，我国医药产业高速发展，药品研发项目已逐渐成为医药企业的核心。我国的药品 研发技术日趋提高，未来很有可能会成为全世界药物研发项目的中心。尽管如此，药品研发项 目过程较长，且具有技术难度大、资金投入多、研究数据要求真实完整等特点。因此医药企业 必须加强对药品研发项目的质量管理，才能为研发项目的成功提供保障。鉴于此，文章基于项 目质量管理理论，对项目质量管理以及医药企业药品研发特点的分析，对L药品研发企业研发 项目质量管理优化进行了深入分析。 本文首先从理论层面，对项目质量管理的基本理论进行了阐述，对项目质量管理的原则及 关键进行了阐述，对新药研发项目质量管理理论进行了阐述。其次对L药企及其新药研发项目 质量管理基本概况进行简要介绍，并介绍了L药品研发企业项目质量管理现状。通过介绍L药 品研发企业两次项目质量管理改进，发现L药品研发企业新药研发项目失败的原因。并提出改 进意见，保障L药品研发企业新药研发项目的顺利进行。最后针对L药品研发企业项目质量管 理推广提出建议，包括本项目PDCA循环法对项目质量管理的实践推广、对L药企的项目质量 管理持续优化推广、对L药企项目质量管理的优化成果推广、对完善新药研发企业项目质量管 理的意识推广。 关键词：项目管理，质量管理，药企，新药研发 L医药公司新药研发项目的质量管理研究 II ABSTRACT In recent years, China's pharmaceutical industry has developed rapidly. Drug Research And Development(R & D) projects have gradually become the core of pharmaceutical enterprises. With the development of drug R & D technology in China, it is likely to become the center of drug R & D projects all over the world in the future. However, the process of drug R & D project is long, and it has the characteristics of great technical difficulty, large capital investment, real and complete research data requirements. Therefore, pharmaceutical enterprises must strengthen the quality management of drug R & D projects to ensure the success of R & D projects. In view of this, based on the theory of project quality management, this paper analyzes the project quality management and the characteristics of drug R & D in pharmaceutical enterprises, and deeply analyzes the optimization of R & D project quality management in L pharmaceutical R & D enterprises. Firstly, this paper expounds the basic theory of project quality management, the principle and key of project quality management, and the quality management theory of new drug R & D project. Secondly, it briefly introduces the basic situation of quality management of L pharmaceutical company and its new drug R & D project, and introduces the current situation of project quality management of L pharmaceutical R & D enterprise. By introducing the two project quality management improvements of L pharmaceutical R & D enterprise, it finds out the reasons for the failure of new drug R & D project of L pharmaceutical R & D enterprise. In order to ensure the smooth development of new drug R & D projects of L drug R & D enterprises, the paper puts forward suggestions for improvement. Finally, suggestions are put forward for the promotion of project quality management of L pharmaceutical R & D enterprises, including the practical promotion of PDCA cycle method of this project for project quality management, the continuous optimization promotion of project quality management of L pharmaceutical enterprise, the promotion of optimization results of project quality management of L pharmaceutical enterprise, and the promotion of awareness of improving project quality management of new drug R & D enterprises. Key words： Project Management, Quality Management, Pharmaceutical Enterprises, New Drug Research and Development 南京航空航天大学硕士学位论文 III 目 录 第一章 绪论 .................................................................................................................................. 1 1.1选题背景........................................................................................................................... 1 1.2研究的目的及意义 ........................................................................................................... 2 1.2.1研究目的 ................................................................................................................ 2 1.2.2研究意义 ................................................................................................................ 3 1.3国内外新药研发项目质量管理研究现状 ....................................................................... 4 1.3.1国外新药研发项目质量管理研究现状 ................................................................ 4 1.3.2国内新药研发项目质量管理研究现状 ................................................................ 6 1.3.3研究综述 ................................................................................................................ 7 1.4研究方法与研究思路 ....................................................................................................... 7 1.4.1研究方法 ................................................................................................................ 7 1.4.2研究思路 ................................................................................................................ 7 第二章 基本理论........................................................................................................................... 9 2.1项目质量管理理论 ........................................................................................................... 9 2.1.1项目质量管理的定义 ............................................................................................ 9 2.1.2项目质量管理的含义 ............................................................................................ 9 2.1.3项目质量管理的特征 .......................................................................................... 10 2.1.4质量管理的发展过程 .......................................................................................... 10 2.2项目质量管理的原则及关键 ......................................................................................... 12 2.3 PDCA循环理论 ............................................................................................................. 13 2.4新药研发项目质量管理理论 ......................................................................................... 13 2.4.1新药研发项目质量管理的发展过程 .................................................................. 13 2.4.2医药项目质量管理的研究现状及观点 .............................................................. 15 第三章 L医药公司新药研发项目质量管理的问题及改进方案 ............................................. 17 3.1 L医药公司基本概况及新药研发项目质量管理现状 ................................................. 17 3.1.1 L医药公司基本概况 .......................................................................................... 17 3.1.2 L医药公司新药研发项目质量管理现状 .......................................................... 18 3.2 L医药公司新药研发项目典型质量管理事件及改进 ................................................. 26 3.2.1 L医药公司第一次新药研发项目典型质量管理事件....................................... 26 L医药公司新药研发项目的质量管理研究 IV 3.2.2 L医药公司第二次新药研发项目典型质量管理事件....................................... 30 3.3新药研发项目质量管理改善设计思路 ......................................................................... 34 3.3.1人员管理 .............................................................................................................. 35 3.3.2设备管理 .............................................................................................................. 36 3.3.3原料管理 .............................................................................................................. 37 3.3.4方法管理 .............................................................................................................. 37 3.3.5环境管理 .............................................................................................................. 38 第四章L医药公司新药研发项目质量管理的推广 .................................................................. 40 4.1本项