NEPG New Drug Hatcher Pilot Trial Base Design Construction And Evaluation

In this thesis, the Northeast Pharmaceutical Group new drug incubation pilottrial base in the construction project management practice for foundation, based onthe domestic pharmaceutical enterprises to research and development of new drugs isweak and more advanced international R&D capability gap in the current situation,analyses the internal and external environment conditions and harsh reality,determine the enterprise construction pilot trial base in the goal and positioning,through the project management team in the pilot trial base construction process inthe functions of the practice, from the project design of a high starting point and highstandard start, step by step, the specific implementation, according to the enterprisefor project positioning, in the domestic pharmaceutical companies in almost noactual case experience can be used for reference, this paper analyses and elaboratedthe whole cycle of construction project in different stage of the problem, on the basisof the more focus on the project construction process design and constructionproblems, analysis, the solution and evaluation, describes the implementation of theproject specific steps, highlighted as an independent project in no ready-madeexperience to be successful draw lessons from the case go through untold hardships.I hope to be able to other similar project project management to provide valuablereference.This thesis consists of five parts, beginning part is the introduction, a briefdescription of the purpose of the project, scope, expected results and meaning.The first chapter introduces the project background and the internal and externalsituation, mainly related to the project location, project selection of subject characteristics, necessity and pressing sex etc.. Introduces the severe competitivesituation, the enterprise must seek long-term development must strengthen thedirection of R&D products.The second chapter through the project design process is introduced, combinedwith the enterprise to pilot trial base project in high standard positioning, as well asenterprises on the market product competition pattern and the internal structure ofstrategic planning, defines the project’s design ideas and specific content, throughdomestic and international two big Design Institute joint efforts, reaches thepredetermined objective, embody the pilot base conception.The third chapter introduces the project implementation stage engineeringconstruction scheme, with professional discourses on the way, will pilot trial baseproject covers the construction content and specific problems, as well as containsand relates to various professional knowledge simply expressed, from which we cansee that the entire project complexity and difficulty.The fourth chapter is mainly controlled drug development and productionprocess must meet mandatory standards--standards for quality control ofpharmaceutical production (GMP) requirements, for standard examination, pointsout the specific need to do what aspects of the job and content, combined with thespecific requirements of the evaluation, puts forward the improvement and thesolutions and measures.Through the discussion and analysis of the final conclusion, a comprehensiveproject is a system engineering, which is one of the most active elements, the need tomobilize all forces to form a team to strive for, in the process of reading many fieldsand professional knowledge. Summed up is a simple truth: the more you know willdo better.