Research On Improvement Of Internal Quality Management Of Hunan Dino Pharmaceutical Co.,Ltd

Medicine is a special commodity for disease prevention and treatment,and its quality is essential not only to people's health and life safety,but also significant to economic development and social stability.Recently,with the advance of the standard of living,people put forward higher demand for the quality and safety of medicine.According to China's "drug production quality management practices(revised in 2010)" and other relevant policies,the management and technical of the pharmaceutical production enterprises should be upgraded.On the other hand,due to the drug quality and safety of China are still in developing,pharmaceutical manufacturers should strengthen the whole process control of the drug quality to ensure the drug safety.Based on the introduction of quality risk management concept,we investigated the trend of pharmaceutical manufacture,and uses the failure mode and effect analysis tool system of quality risk management from "people,machine,material,law and ring".The risk factors in the process of drug production and quality management of Hunan Dinuo Pharmaceutical Co.,Ltd.were analyzed.Then based on the severity of risk assessment,this research proposed optimized document system and standard material management.Furthermore,we recommend improving quality risk management awareness and strengthening training to ensure the quality of risk management system more effective.After six months of implementation of the quality risk improvement measures,Hunan Dinuo Pharmaceutical Co.,'s quality risk management has achieved phase achievement.Risk assessment of the previous risk points,serious risk and high risk risk points have been effectively controlled,reduced to medium risk and low risk.In present study,Hunan Dinuo Pharmaceutical Co.,Ltd.was chosen as a case for quality risk research.Based on the real situation of the company,in addition to finding a proper way to reduce the drug quality risks,we further seek to establishing a long-lasting and feasible quality risk management system.Given that t he quality risk management is a continuous improvement process,quality of risk management system and risk management standards should be constantly improved.Only then can Hunan Dinuo Pharmaceutical Co.,Ltd.keep its advantage in severe market competitio n and lay a solid foundation for sustainable development.