基于GMP的TD制药公司项目范围管理研究
发布时间：2019-07-02 19:09
【摘要】：制药工业法规的要求非常严格,其中一个最重要的法规为药品生产质量管理规范(GMP:Good Manufacturing Practice)。2015年12月31日,中国所有的制药企业都要达到新版GMP的要求。但改造与新建的项目满足GMP的要求情况却不尽人意。资料表明,制药项目失败的最重要原因与GMP范围管理有关。论文从TD制药公司的GMP范围问题出发,同时分析TD公司制药工程项目存在的主要GMP范围问题,提出TD公司制药工程项目范围管理过程中的GMP的范围管理问题,同时找到了TD公司制药工程项目范围管理中GMP范围管理问题3方面的成因,在对各因素分析的基础上找到对策,得出加强项目的前期规划,加强施工方的管理,加强需求的控制与变更控制的结论。并通过项目定位、合理选择建设时机、选择承包方式与承包商、参与施工方的团队建设、建立GMP小组等,将对策具体化。本论文通过研究分析为TD公司制药工程项目在进行GMP管理时,把GMP范围管理作为制药工程项目范围管理的一个关键点,找到了制药工程项目GMP范围管理问题的成因,并提出解决的方法,同时将解决的方法应用到TD制药公司制药工程项目建设中,通过工程实例效果分析,为研究提供了有力的支撑。
[Abstract]:The requirements of the pharmaceutical industry regulations are very strict, one of the most important of which is the drug production quality management specification (GMP:Good Manufacturing Practice). December 31, 2015, all pharmaceutical companies in China have to meet the requirements of the new GMP. However, the transformation and new projects to meet the requirements of GMP is not satisfactory. The data show that the most important reason for the failure of pharmaceutical project is related to GMP scope management. Starting from the GMP scope problem of TD Pharmaceutical Company, this paper analyzes the main GMP scope problems existing in TD Pharmaceutical Engineering Project, puts forward the scope Management problem of GMP in the process of TD Pharmaceutical Engineering Project scope Management, finds out the causes of GMP scope Management problem in TD Pharmaceutical Engineering Project scope Management, finds out the countermeasures on the basis of the analysis of various factors, and obtains the preliminary planning of strengthening the project. Strengthen the management of construction, strengthen the control of demand and change control conclusion. Through the project positioning, reasonable selection of construction timing, selection of contracting methods and contractors, participation in the team building of the construction party, the establishment of GMP groups, etc., the countermeasures will be concrete. Through research and analysis, this paper takes GMP scope management as a key point of pharmaceutical engineering project scope management in GMP management of TD pharmaceutical engineering project, finds out the cause of formation of GMP scope management problem of pharmaceutical engineering project, and puts forward the solution method. At the same time, the solution method is applied to the construction of pharmaceutical engineering project of TD Pharmaceutical Company. Through the analysis of the effect of engineering examples, it provides a powerful support for the research.
【学位授予单位】：中国石油大学(华东)
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.72
[Abstract]:The requirements of the pharmaceutical industry regulations are very strict, one of the most important of which is the drug production quality management specification (GMP:Good Manufacturing Practice). December 31, 2015, all pharmaceutical companies in China have to meet the requirements of the new GMP. However, the transformation and new projects to meet the requirements of GMP is not satisfactory. The data show that the most important reason for the failure of pharmaceutical project is related to GMP scope management. Starting from the GMP scope problem of TD Pharmaceutical Company, this paper analyzes the main GMP scope problems existing in TD Pharmaceutical Engineering Project, puts forward the scope Management problem of GMP in the process of TD Pharmaceutical Engineering Project scope Management, finds out the causes of GMP scope Management problem in TD Pharmaceutical Engineering Project scope Management, finds out the countermeasures on the basis of the analysis of various factors, and obtains the preliminary planning of strengthening the project. Strengthen the management of construction, strengthen the control of demand and change control conclusion. Through the project positioning, reasonable selection of construction timing, selection of contracting methods and contractors, participation in the team building of the construction party, the establishment of GMP groups, etc., the countermeasures will be concrete. Through research and analysis, this paper takes GMP scope management as a key point of pharmaceutical engineering project scope management in GMP management of TD pharmaceutical engineering project, finds out the cause of formation of GMP scope management problem of pharmaceutical engineering project, and puts forward the solution method. At the same time, the solution method is applied to the construction of pharmaceutical engineering project of TD Pharmaceutical Company. Through the analysis of the effect of engineering examples, it provides a powerful support for the research.
【学位授予单位】：中国石油大学(华东)
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.72
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