Exploring the Importance of Quality Control of Pharmaceutical Excipients from the Pollution Incident of Ethylene Glycol and Diethylene Glycol
Objective:To clarify the importance of quality control of pharmaceutical excipients by reviewing the incidents of ethylene glycol and diethylene glycol pollution and related regulatory requirements. Methods:Through sorting out the pollution incidents of ethylene glycol and diethylene glycol,as well as the relevant regulatory requirements issued by the United States and the World Health Organization,and combining with the warning letters of ethylene glycol and diethylene glycol pollution issued by the FDA,this paper puts forward some suggestions on the quality control of pharmaceutical excipients. Results and Conclusion:Glycerin and other pharmaceutical excipients by ethylene glycol,diethylene glycol pollution will produce more serious drug pollution events. The World Health Organization has repeatedly issued global medical alerts,FDA has also repeatedly warned against ethylene glycol,diethylene glycol pollution. The quality of pharmaceutical excipients and the quality of drugs is closely related. This paper analyzes the causes of ethylene glycol and diethylene glycol pollution,and puts forward suggestions on the quality system construction of excipient manufacturers,the control of excipient circulation links,the quality responsibility of drug manufacturers,the development and improvement of testing methods and equipment,and the coordination and cooperation of global regulatory authorities. It hopes to provide references for the industry to further improve the quality management and control of pharmaceutical excipients.
ethylene glycoldiethylene glycolpharmaceutical excipientswarning lettergood mannfacturing practicesquality management system
万方数据
维普
