Summary of medical quality work

In order to thoroughly implement the spirit of the National Quality Work Conference, strictly implement the "Special Provisions of the State Council on Strengthening the Safety Supervision and Management of Food and Other Products", and receive the "Special Action Plan for the Quality and Safety of Medical Devices for Printing and Distributing Medicines" and the "Regulations issued by the District Government Office" After the notice of the product quality and food safety special rectification action plan of Longmatan District of Cangzhou City, the leaders of the bureau attached great importance to it and carefully organized and implemented the “Dongmatan Food and Drug Administration of Cangzhou City, Sichuan Province” issued and issued the drug according to the regulations. The Notice on the Special Remediation Action Plan for Medical Device Quality and Safety requires a special rectification for 4 months. The progress of the special rectification work is summarized as follows:
The first is to establish institutions, implement responsibilities, clear ideas, and formulate plans. A special rectification action leading group with party secretary and director Zhou Xiaoquan was set up, which defined the division of responsibilities and laid the organizational foundation for the smooth development of special rectification actions. The bureau has held several party group meetings, special research and deployment of special rectification action plans, clear rectification content, methods and steps, scientific organization and overall arrangement. The “Notice on the Action Plan for the Special Remediation of Quality and Safety of Pharmaceutical Medical Devices” issued by Longmatan Food and Drug Administration of Cangzhou City, Sichuan Province was formulated and issued.
The second is extensive publicity and training. From September to October of XX, the company organized and organized nearly 1200 person-times of drug management and medical management personnel in the district to conduct special training and distributed more than 3,000 publicity materials to help them understand the profoundness of the Special Regulations. Connotation and standardize its business behavior. Strengthen corporate quality awareness and fully mobilize corporate initiative. Since the implementation of the special rectification actions for the quality and safety of pharmaceutical medical devices, the SIPO has organized many pharmaceutical wholesale enterprises, retail enterprises and chain enterprises with chain stores in our jurisdiction to hold meetings, arrange relevant work, and fully mobilize enterprises to let Enterprises truly establish the awareness of quality first, let them take the initiative to do self-examination and self-correction work in accordance with relevant requirements.
The third is to strengthen supervision and focus on implementation. Since September, our bureau has carried out inspections on nearly 250 drug-related units in the area under its jurisdiction. A total of 185 law enforcement officers have been dispatched, 50 vehicles have been dispatched, 11 cases have been filed, involving 8400 yuan of gold, and 6,000 illegal proceeds have been confiscated. Yu Yuan, a fine of 27,000 yuan, banned two illegal enterprises. After nearly four months of rectification actions, the production, operation and use of drugs were further regulated, the order of the pharmaceutical market was further improved, the quality of medicines was further guaranteed, and the awareness of rational use of medicine by the people was further enhanced. The main work carried out is:
Focusing on the implementation of gmp and standardizing the production of pharmaceuticals in the production of pharmaceuticals, the SIPO will focus on the implementation of quality management responsibilities of pharmaceutical manufacturers and the purchase of raw materials, qualifications, batch production records and quality inspections. The supervision of Sichuan Baoguang Pharmaceutical Co., Ltd. and Zhangzhou Jianping Hospital's preparation room in the area was strengthened; for the problems found in the inspection, the Office separately proposed rectification opinions. During the special rectification period, the bureau carried out a total of 3 inspections of Sichuan Baoguang Pharmaceutical Co., Ltd., conducted 2 inspections of Zhangzhou Jianping Hospital, and dispatched 18 inspectors.
Focusing on the implementation of gsp and standardizing the operation of pharmaceuticals in the circulation of drugs, the SIPO strengthened the focus on the implementation of gsp, the qualifications and training of enterprise personnel, and the existence of affiliated operations and out-of-scope operations. Supervision and inspection of pharmaceutical business enterprises within their jurisdiction. In particular, in response to the "7.26" rabies vaccine for dummy use and the case of Yongzheng sales personnel who have been seized by the Office for unlicensed operation, the SIPO has proposed two measures to strengthen the management of enterprise procurement personnel: First, the fixed drug purchaser is responsible for The drug procurement work between enterprises within the jurisdiction; Second, the enterprise will report the sales staff to the bureau for filing. This effectively prevents the phenomenon of “extracorporeal circulation” of drugs and “only recognize faces and not recognize enterprises”. Since the beginning of the rectification campaign, the bureau has dispatched 112 inspectors and inspected more than 210 pharmaceutical companies. In response to violations of laws and regulations, they have been required to correct them in accordance with the relevant laws and regulations. Four of the pharmaceutical companies have filed for the case.
Increase the supervision of medical device management enterprises and standardize the operation of medical devices in the operation of medical devices. The SIPO will focus on whether the operating enterprises operate according to the licensing conditions, whether the operating conditions are lowered without authorization, and whether the purchasing channels are standardized. For the supervision of medical device operating enterprises, 2 cases of illegally operating medical devices were investigated and dealt with. In this rectification operation, a total of 15 law enforcement officers were dispatched, and more than 20 medical device management enterprises were inspected, and one case was investigated and investigated.
Focusing on the regulation of pharmacy management in medical institutions, and standardizing the use of drugs and medical devices in the use of drugs, the SIPO has focused on medical equipment purchase channels, drug purchase records, drug storage conditions, and pharmacy personnel qualifications. Institutions use the quality supervision of medical devices; at the same time, in order to further standardize the use of drugs and medical devices in medical institutions, and strengthen the quality management of medical devices in medical institutions, the Bureau and the Health Bureau jointly issued the "Implementation Plan for the Establishment of Standard Pharmacy Activities in Longmatan District of Zhangzhou City" The objectives of the creation were clarified, specific implementation steps were put forward, and detailed acceptance criteria were formulated to promote the management of pharmacies in medical institutions in our district on a more scientific and standardized track. In this special rectification, the bureau issued a total of 46 law enforcement officers, and inspected 58 medical institutions and filed a case.
Strengthen the supervision of special drugs, standardize the sales and use of special drugs in the supervision of special drugs, the bureau concentrates personnel and time, the institutions and personnel who use and operate special management drugs units, purchase channels, storage management and storage conditions The sales and use management, transportation management, safety management, and statistical reports were comprehensively inspected. A total of 36 inspection personnel were dispatched, and a total of 28 operating enterprises and users were inspected.
Strengthen the inspection of drug advertisements, standardize the drug advertisement advertising market, further rectify the drug and medical device advertising and publicity market, and strengthen the advertising monitoring. The Office has intensified the inspection of illegal advertisements and resolutely handed over advertisements that do not meet the requirements. In this special rectification, nearly 4,000 illegal printed materials were collected and 57 billboards were dismantled.
Highlight the key points of comprehensive flowering, set up a typical model with points and face, and enhance the overall image of the pharmaceutical machinery enterprises in our district.
In order to meet the guidance of higher-level inspections, and better improve the level of operation and service level of drug-operated enterprises in our district according to law, on the basis of the rectification of the previous stage, the members of the leading group will be grouped and contracted from November 22, and the four regions will be identified as the key points. To select the 22nd store of Shengjie Pharmaceutical Co., Ltd. of Nanguang Road and the small pharmacy of Huilongwan People's Hospital as a demonstration store and surrounding areas, focusing on the Red Star Farmers Market and Chunyu Road Food Street Regional Pharmacy, in the implementation of eight aspects The content of the work, and combined with the actual situation of our district, do a good job of "five unification", that is, unified wall materials, unified clothing badges, unified classification management logo, unified data box, unified label. So far, the key areas, especially the store halls of the two demonstration stores have changed a lot. The store is clean and tidy, there are no illegal advertisements, the purchase bills are bound, the systems are well executed, the qualifications of the employees are complete, and the drug safety awareness is complete. And service awareness has increased significantly.