The Study Of Quality Control And Management For GE Healthcare Shanghai Company Expansion Project

The pharmaceutical construction project is apparently impacted by kinds of factors such as investment, economy, and technology/rules due to long lead period, also with high complexity and high quality requirement. These project needed be reviewed and approved by SFDA with special high requirement on quality side when GMP (Good manufacturing practice) auditing. Due to the new GMP (version2010) standard issued currently quality management and control is more focused in pharmaceutical capital project and it took obvious progress step by step. But because the original pharmaceutical construction standards about quality is not perfect and supervising system is not strong enough, there are most of deferent levels pharmacy factory in china and so some big bad accident happened in past years. So the new GMP (version2010) defines and clarifies the concept and requirement for the quality management. The quality control and management is important cycle applying in facility design and construction phase. Related person should take more attention to this.This file is subject to quality management study basing the case about the expansion project of GE healthcare shanghai company, state briefly below points:The first is introducing the quality development for the Pharmaceutical area in the world and it’s necessary to executer good quality for project execution. The second is stating the quality definition and characters for this project to show what the changeling for this. The third is remarking the problem of the case project met and how to execute the good quality control and procedure by some case analysis. The fourth is raising the quality strategy proposal for fitting this case project. The fifth is describing the quality method for deferent system. The final is summary of the suggested method for the quality control and the future expectations.