Study On Drug Retail Companies With GSP Certification In Tianjin

Objective:The "Drugs Management Quality control Standard"(GSP) authentication is the National Food Drugs Administration legally administering the work which forces the national drugs management enterprise to implement.Tianjin has started since 2003 to carry out the GSP authentication work,first time experiences the GSP authentication to 2008 the drugs retail sales enterprise to authenticate the certificate to expire one after another,must authenticate.This research plans through to understand Tianjin through the GSP authentication drugs retail sales enterprise management condition,to discover the existing question,to authenticate the work the smooth development to provide the advisory opinion,and will carry on the discussion to the drugs retail sales enterprise future trend of development.Method:The questionnaire takes the drug-retail enterprises with GSP Certification in Tianjin as its study object.The questionnaire arises from seven aspects,which are respectively the status of professionals on quality control,quality control system and operation,purchase and sales of medication,training and development orientation of these enterprises.The track survey report launched by Tianjin Food and Drug Administration citywide reveals that nearly 70%drug retail enterprises somewhat run counter to GSP rules.Following the formula N=u_α~2(1-p)/δ~2p=1.96~2(1-0.70)/0.1~2×0.70≈164 and in consideration of the admissible error and 10%bounce rate,N is calculated to be around180.By the end of 2008,a total number of 220 questionnaires are handed out,of which,198 copies were fed back.And 196 questionnaires,being sieved and sorted,prove to be effective,with the effective feedback rate of 99.98%.And then based on systematic analysis and study of the effective questionnaire,the conclusion is drawn.Results:The Tianjin Drugs Retail sales Enterprise specialty quality control personnel is good to the drugs GSP standard understanding grasping degree,is familiar with own work responsibility and the work content,has certain veto to the enterprise drugs quality.Enterprise quality control system is essentially perfect.The quality control system can periodically inspect,achieve in the sales drugs process take the drugs quality as the premise,and consummate various links to the drugs to carry on the quality control the measure.The enterprise salesroom environment does not have the pollutant neatly,the ground wall surface smoothly,the complete shelf counter,and the strike marking.The drugs classification place is reasonable,in the shop warm light,fire security,illumination well appointed hardware facilities and so on controls, ventilates,evades.The movement is good.The enterprise can regularly carry on training to the staff,but training effect pending enhancement.Conclusion:The survey finds that 91.8%professionals on quality control in enterprises have a good commanding of GSP rules.These professionals,well acquainted with their work responsibility and scope,have their deciding vote on the drug quality in enterprises.In the aspect of quality control system and operation, 94.9%enterprises have sound system in place and 99.5%enterprises conduct inspection and assessment on their systems regularly.As regard to management on the purchase and sales of drugs,91.0%enterprises exercise and improve strict control over sales operation for the high quality of drugs.In terms of the tidiness and infrastructures,93.4%enterprises keep their drug storage(store) spick and span with complete drug shelves,clear labels,and drugs in order.The hardware facilities for ventilation,shading,fire-fighting and lighting are complete and in good working state. While employees normally receive regular training,the training effectiveness needs further improvement.