| Drug is a special commodity,From the perspective of the usage of the drug,patients cannot recognize the inner quality except the drug secondary package.Patients can take the drug only under doctors’ advice,not the decisions made by themselves.The treatment effects can be affected by many factors,e.g.method of usage,quantity and timing.Any misusage,over dosage may affect the life of patients.So quality of drug is very critical.Any problem cure during the drug risk management in design,development,registration,production,sales and transportation will bring tremendous risk to patients.The public required higher standards on safety and effectiveness as China’s economic development and socialization progress grow up.So risk management is a valid method in drug quality management.Take N pharmaceutical company’s cold chain logistic as a study object,we found that N pharmaceutical company’s risk recognition procedure is not complete,risk assessment factors are not clearly defined and risk treatment is not well established when analyzed the all cold chain logistic process.Expert investigation was used to recognize all risk factors in four processes,receiving process,storage process,dispatch process and transportation process.Using FEMA analysis tool,all the risk factors are classified and prepare the prevention plan in equipment,technology,3rd party logistics providers and reorganization of transportation route to reduce the risk in cold chain logistics procedure.The risk management process is involved in quality management system,risk management team training plan is established which improve the quality system,reduce the risk in cold chain logistics and enhance the competitiveness of N pharmaceutical company in pharma industry.The study results can be certain reference to other pharmaceutical companies. |