Research On Quality Improvement Mode Of A Pharmaceutical Company Under GMP

In recent years, the quality management level of medicine industry get improved greatlythrough wide fulfilling GMP standard manufacturing among domestic pharmaceuticalenterprises . But some new problems emerged along with continue producing under GMPenvironment. One of which , how to develop quality improvement work based on GMPbecame one focus. As one big state owned enterprise , A pharmaceutical company has alwaysbeen deploying GMP related works .All products of A pharmaceutical company past GMPaudit from Chinese State Drug Administration and some of them approved by FDA and COS.However, the GMP based quality control system of A pharmaceutical company can notprevent quality problems from happening .Moreover, production under poor quality levelresult in cost increasing and future development of A pharmaceutical company is hindered.This dissertation starts from actual situation in China now. The conclusion ofpharmaceutical companies should deepen quality improvement on GMP basis is given.As to detailed problems emerged in A pharmaceutical company ,analysis of the reasonsis made in this paper and advice of what kind of quality improvement mode should be takenwas provided. Said solution includes establishing quality culture ,taking six sigma DMAICprogress as tool to eliminate unstable factors stated in human, machine, material, craft, testing,environments.