Sanming promotes the standardization system of daily drug supervision

What is the daily supervision and how? Sanming food and Drug Administration breaks through the original supervision experience and habits, implements the daily supervision standardization system, standardizes the law enforcement behavior through unified inspection standards and standards, and effectively prevents the occurrence of problems such as wide and strict law enforcement standards, inspection of missing items and omissions, random inspection and human condition inspection Chen Hong, deputy general manager of Sanming Luyan Pharmaceutical Co., Ltd., said: "in the past, enterprises had a fluke mentality when dealing with inspection, and province is province After the implementation of the regulatory standardization system, enterprises have no way out They should do well one by one according to various standards, which effectively promotes the improvement of enterprise management level " "The standardization of daily supervision is to unify the inspection items, inspection contents, inspection methods and inspection requirements in the form of standardized forms in a comprehensive way for the supervision requirements of all kinds of supervision objects." Huang Weijun, director of Sanming Municipal Bureau, said: "the purpose of this is to make every inspection thorough and in place through standardization, so as to prevent missing items and unfair law enforcement." Sanming Municipal Bureau has formulated the standardized daily supervision form, which covers all fields of "three products and one instrument", and is divided into 17 types of daily supervision forms Each form has clear inspection items, methods, key points and results For example, according to the standard daily supervision form of sterile drug manufacturing enterprises, the inspection items of this type of enterprises are divided into 11 major items and 86 key inspection sub items, such as organization and personnel, equipment, document management and production management Deng Xuquan, a marketing staff member of Sanming Municipal Bureau, told reporters: "in the past, based on experience, there would always be some missing items and omissions, which could not be put in place at one time Now, check according to the form, without any omissions." In order to effectively implement the standardization system, Sanming Municipal Bureau organized unified training for system supervisors and enterprises related to "three products and one device" in the whole city, explained the "standardization daily supervision form" one by one, so that the supervisors could understand how to use the standards and the supervision objects could abide by the standards The bureau also organically combines the use of standardized daily supervision form with on-site inspection records, requiring supervisors to register and supervise the rectification of problems found in the inspection in a timely manner; after each inspection, relevant information in the standardized daily supervision form shall be entered into the supervision electronic file system as a basis for credit rating of administrative counterparts The implementation of the standardization system has integrated the limited regulatory power, improved the efficiency of food and drug supervision in Sanming City, and also received favorable comments from the administrative counterparts Liu JUANJUAN, store manager of Sanming shopping mall of Fujian Huihao Sihai chain Pharmaceutical Co., Ltd., said: "in the past, there were more inspections by the pharmaceutical supervision department Today, this department comes to check, and tomorrow, that department comes to check Customers will think that there is something wrong with the management of the enterprise Now we have implemented the regulatory standardization system The supervisors have checked all the projects at one time If there is any problem, it is clear and targeted We welcome such inspection " Sanming County food and drug regulatory authorities also reflected that the implementation of regulatory standardization system makes the inspection more purposeful, and the lack of items and omissions in the inspection less In the recent special action to crack down on "four non" health food and "two dozen and two construction" of drugs, Sanming Municipal Bureau actively coordinated with relevant departments to carry out special rectification with supervision standardization as the starting point It has given enterprises 43 warnings, ordered them to correct, investigated and dealt with more than 20 cases, and effectively purified the market order Editor's note: after the reform of the food and drug regulatory system, the supervision and law enforcement work will face the situation of further broadening the scope and increasing the difficulty, and the grass-roots food and drug regulatory departments will face a more severe test Sanming Municipal Bureau carried out the daily supervision standardization system, prevented the inspection missing items and omissions from the perspective of the supervision department, and improved the inspection quality and supervision efficiency From the perspective of administrative counterpart, it reduces the inconvenience and impact of cross and repeated inspection on enterprises; at the same time, the formulation of standardized daily supervision form also sets a clear "template" for enterprises to improve their own quality management level, which can urge enterprises to carefully compare the standards, take the initiative to correct the deviation, and earnestly fulfill their quality and safety responsibilities Such supervision and law enforcement are more active and effective.