RESUMO
OBJECTIVE@#Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement.@*METHODS@#Classify and analyze the on-site audit findings from different type of medical device manufacturers.@*RESULTS@#The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high.@*CONCLUSIONS@#The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.
Assuntos
Indústrias , Controle de Qualidade , Fatores de TempoRESUMO
Objective To establish a HPLC method for the determination of magnolin in Xuetie Dingchuan Plaster.Methods The HPLC chromatographic condition was as follows: the analytical column was Lichrospher C8(4.6mm?250mm,5?m),the mobile phase consisted of A(acetonitrile)∶B(1.55%tetrahydrof uran-water) 34∶66,the flow rate was 1.0 mL?min-1,the detected wav elength was 278 nm,and the column temperature was 30 ℃.Results The calibr ation curve was linear(r=0.9999) in the range of 0.42～ 5.25 ?g for magnolin,the average recovery of the method was 100.50 %,with RSD 2.22 %(n=9).Conclusion The method is accurate,simple and stable,and can be used for the quality control of Xuetie Dingchuan Plaster.