Qingdao adopts the scoring management mode of bad behavior in drug production

In order to further strengthen the supervision of drug safety and ensure the origin of drug production, Qingdao City, Shandong Province, formulated and promulgated the "Qingdao Drug Production Bad Behavior Score Management Measures." Methods Draw on the traffic police to deal with the pattern of illegal deduction of points, according to the enterprise illegal violations or circumstances of the risk level, different defects to implement different score points.
in order to strengthen the supervision of the source of drug production, Qingdao Municipal Bureau, drawing on the mode of traffic police to deal with illegal deduction of points, formulated and promulgated the Measures for the Administration of Score of Bad Behavior in Drug Production in Qingdao.
Measures will be the city in accordance with the law to obtain the "drug production license" and "drug GMP certificate" in the production of pharmaceutical production enterprises into the scope of scoring, serious defects each score 100 points, the main defects each score 20 points, general defects each score 2 points. The scoring method is based on one year for one cycle, with a limit of 100 points per cycle. A new scoring cycle begins one year later, and the original score is eliminated. For violations found in the same inspection, the cumulative score shall be made, and if the problems found in the inspection have not been corrected in place, double the points. When the score accumulates to a certain score, the enterprise is given the corresponding treatment until the enterprise GMP certificate is recovered.
methods clarify the municipal and district level drug production supervision responsibilities, but also clear the basis for inspection, inspection methods, inspection frequency, scoring scale, and so on, and further implement the hierarchical, quantitative, trace supervision; The effective improvement of regulatory effectiveness, the added score as an important basis for the formulation of next year's regulatory plan, helps to determine the enterprise risk level and weak links, scientifically formulates the daily inspection plan, the limited regulatory power into the high-risk key links and enterprises, to achieve accurate supervision. In the first half of 2016, 85 batches were tested in the pharmaceutical production sector, and no unqualified batches have been found.
the implementation of the system, but also always remind enterprises to strictly implement the main responsibility not to repeat the mistakes, greatly enhance the enterprise's subjective initiative in production in accordance with the law. Shanghai Pharmaceutical Group Qingdao Guofeng Pharmaceutical Co., Ltd. and Qingdao Guoda Biopharmaceutical Co., Ltd. introduced more stringent internal management measures, detailed scoring implementation program, the score and employee income incentives linked, so that responsibility and pressure to each post and employees. (Shandong Net, China)