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论文编号：	7045
作者编号：	2120122900
上传时间：	2014/12/10 21:32:04
中文题目：	制药企业药品研发质量控制研究
英文题目：	Quality control of pharmaceutical companies'' drug research- A Case Study of Tasly Pharmaceutical Group
指导老师：	李季
中文关键字：	药品研发；质量控制；医药企业
英文关键字：	Drug Research; Quality Control; Pharmaceutical Companies
中文摘要：	随着人们对健康、安全意识的提高，人们对药品的质量也越来越关注。如何保障药品的质量，在研发、生产、流通和使用环节都很重要，特别是研发阶段，是药品质量控制的源头。当今，在制药企业对于药品研发阶段的质量控制备受关注。本文以天士力制药集团为例，对药品研发过程的质量控制进行了研究。 本文共有6个部分，第一部分为绪论，主要介绍论文选题的背景、现实意义，论文的研究方法和框架结构；第二部分为质量管理相关理论概述，主要介绍本文研究过程中涉及和运用到的相关理论，具体为质量管理的发展和理论学说，以及质量控制的相关理论；第三部分为制药企业药品研发质量现状分析，主要介绍我国药品质量标准和质量控制现状及存在的问题，以及问题的根源；第四部分为药品研发质量的因素控制，主要介绍了药品研发过程中如何进行因素的控制，主要包括药品研发技术因素控制、环境因素控制以及人才因素控制，详细阐述了因素控制的具体内容；第五部分为药品研发质量的过程控制，从药品研发评估到注册批件的转移方面介绍了在药品研发过程中的关键控制环节；第六部分为天士力制药集团在药品研发质量控制方面的具体实施情况。 基于以上6部分的研究，得出6条关于药品质量控制的结论，同时该研究可对药品研发质量控制起到呼吁和帮助的作用。
英文摘要：	With the improvement of people's health and safety awareness, people are increasingly concerned the quality of the medicines . How to protect the quality of medicines in the research, production, distribution and logistics procedures are very important, especially in the research part, which is the source of drug quality control. Today, the pharmaceutical companies for quality control in drug research and development stage is also concerned. In this paper, take Tasly Pharmaceutical Group as an example, the quality control of drug development process is studied. In this paper, we have six parts. The first part is an introduction which describes the background, significance, research methods and the frame structure. The second part is an overview of quality management theory which this paper focuses on the process involved and apply to the relevant theory and doctrine for the development of specific quality management, quality control, and related theories. The third part is the quality analysis for the status of drug development pharmaceutical companies, mainly on China's pharmaceutical quality standards and quality control situation and existing problems. The fourth part is the quality of the factors controlling the development of drugs which focuses mainly on the drug development process and how to control factors, including drug development technical factors control, environmental control, and human factors control. The fifth part discovers the process of drug development quality control which discusses from drug discovery to assess transfer of the registered documents relating introduced in the drug development process. The sixth part specifically discusses the quality control of drug development implementation by the example of Tasly company. Based on the above six parts, we can draw six conclusions about drug quality control, as well as the study of drug R&D quality control can play the role of appeals .
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