Design And Implementation Of Automatic Trace-code Assigning And Association System For Drug Traceability

In order to strengthen the control over the counterfeit of counterfeit medicines,pharmaceutical quality traceability systems based on trace code are established by the State Administration of Food and Drug as well as the Ministry of Agriculture.In these systems,the principle of “one code per pack” should be followed by pharmaceutical enterprises,and the information of packing,delivering into and out of warehouse are able to be recorded and managed,and can be uploaded to the national unified regulatory platform.In this way,information disclosure and transparency of drug quality management is guaranteed from the source and process,meanwhile,it also provides information for the management of circulation of drugs.Therefore,the work of trace-code assigning,collecting,and associating,in the process of packing,delivering into and out of warehouse must be well finished by pharmaceutical enterprises.However,there are many problems in the pharmaceutical enterprises during the implementation of the traceability system,such as the lack of trace-code assigning,collecting and associating system and low level of automation,which caused the enterprise's needs and national mandatory requirements difficult to coordinate.Thus,based on the comprehensive analysis of a number of enterprise's needs and the requirements of the national traceability system,an automatic trace-code assign and association system was proposed by automated control technology,electrical circuit technology,software engineering technology and database technology,to support the production of enterprises without affecting the normal production and meet the requirements of national quality supervision simultaneously.The thesis mainly includes:(1)A scheme of automatic trace-code assigning and association system is developed based on the comprehensive analysis of a number of enterprise's needs and the requirements of the national traceability system.(2)A control scheme of automatic production line for association is designed based on the requirements of auto association.The devices of the automatic production line,such as printer,scanner,control card,solenoid valve,sensor,etc.are integrated,by device interface integration method based on dynamic link library.An association rejection method based on queue count is proposed to realize the abnormal control of automatic correlation production line.(3)An automatic trace-code assign scheme is designed according to the requirements of auto trace-code assigning and “one code per pack”,and an on-site trace-code assign software is developed by RS232 serial communication technology;A PDA based trace-code collecting software is developed according to the requirements of information collecting of delivering out of warehouse.(4)A Win Form based information integration management software is developed to support the integration of information management according to the needs of information integration and management of whole process.