Medical network on April 13 - today, the food and drug administration announced in fujian province "in 2017 the province pharmaceutical trading enterprises GSP track inspection plan, this year will be about 137 pharmaceutical trading enterprises implement tracking check, including certification expiration of two years of 57 pharmaceutical wholesale enterprises, 80 drug retail chain headquarters and drug retail enterprises. 

 

Check the division of labor 

 

(a) the provincial food and drug certification review center is responsible for fujian province Han Ting group co., LTD. 36 pharmaceutical wholesale enterprises, such as the GSP tracking check on-site inspection plan formulation, and organize their implementation. 

 

Note: fujian good comfortable big pharmacy co., LTD., as well as the districts municipal bureau organization tracking check list. 

 

 

 

(2) in various districts municipal (including pingtan comprehensive experimental rc, similarly hereinafter) bureau is responsible for this area in 2016 has been the implementation of flight check pharmaceutical wholesale enterprises and drug retail chain headquarters GSP tracking check on-site inspection plan formulation, and organize their implementation. 

 

Note: fujian good comfortable big pharmacy co., LTD., as well as the provincial certification review center organization tracking check list of wholesale enterprises "; Fujian good medicine big pharmacy chain co., LTD in fuzhou, putian two area check list. 

 

 

 

(3) the various districts municipal bureau or county (city, area) bureau is responsible for organizing the jurisdiction pharmaceutical retail enterprise to track inspection. 

 

In addition, in this paper, the attached check list, as has been listed as the flight check, track inspection organizations, along with all the inspection report issued by respectively. Drug retail chain headquarters shall be carried out together with chain stores track inspection, to improve the efficiency of track inspection. 

 

Work arrangement 

 

(a) check the time 

 

Provincial food and drug certification review center, various districts city bureau should be completed before October 31, 2017 GSP track inspection task, on November 10th will track inspection written summary material submitted to the provincial food and drug supervision bureau (the tube called "ShengJu") medicine circulation regulation. 

 

(2) inspection method 

 

GSP tracking check should be based on "the drugs management quality management standard" and "drug-handling quality control standard for on-site inspection guidelines (revised), and combining with the state administration of the requirement of the announcement no. 94, 2016, a comprehensive check the running status of drug quality management system clearly check the key content and key link, truthfully record the defect project. 

 

(3) the test results 

 

In accordance with the drug management and the quality control standard for on-site inspection guidelines "(revised), check the result as" violation of drug management quality management standard, rectification within a time limit of "drugs wholesale, retail chain headquarters), by the municipal bureau to inspect enterprise improvement completion, and issue a corrective review report; Results judged to be "a serious breach of drug management quality management standard, revocation of the pharmaceutical management quality management certification certificate" of drugs wholesale, retail chain headquarters), organize inspection unit should be at the end of the checking within 5 working days to submit the ShengJu examination result, after ShengJu audit will be revoked in accordance with the "drug-handling quality management standard certificate". Traversing the site inspection found in enterprise management behavior of illegal or irregular act, shall be handed over to the enterprise local regulatory authority in accordance with the law case is investigated, and promptly report ShengJu.