The Introductions、suggestions And Corrective Actions Of Gsp Inspections And Track-Inspecton

The abbreviation of drug’s GSP regulations is "good supply practices", which is known as regulations of drug’s quality on market. GSP is a quality management system on Drug purchase, check and acceptation, storage and transportation, sales and after-sale services, which makes sure there is no problems on quality. This system includes organization and structure, process management, Facilities and equipment management and so on. It gives expression to the idea of "QFP"(quality from process) deeply.The international GSP regulations are popularized from last century. According to their own situation, many countries established and implemented their GSP/GDP (good distribution practices) regulations. Chinese GSP regulations have started up lately but developed very fast. Current GSP regulations are established and implemented in2000. Based on old GSP regulations, new GSP regulations which contain the new ideas of Modern logistics, cold chain management, qualification and validation will be established and implemented next year.Implement of GSP has achieved remarkable results in Zhejiang province, to make sure there is no quality accidents happened in Zhejiang’s drug market. Working in Zhejiang certification center for drugs, I have accumulated lots of experiences on inspections and first hand data. Through sorting out and comparison of GSP inspections and track-inspections in recent years(2010、2011), I sum up the current situation of Zhejiang’s GSP inspections in recent years, and make a suggestions and corrective actions on GSP inspections in Zhejiang Province.