Wuxi strengthens veterinary drug GMP supervision with "four measures" - April 19, 2007

　　GMP for veterinary drugs is short for "Good Manufacturing Practice for Veterinary Drugs." It is the basic standard that must be followed in veterinary drug production, serving as a passport for international trade in veterinary drugs and a key tool for veterinary drug management departments to manage veterinary drug manufacturers and products. Our city currently has ten veterinary drug GMP production enterprises, including one raw material drug enterprise, one biological product enterprise, and eight livestock, poultry, and aquatic drug and disinfectant enterprises. In recent years, in accordance with the provincial department's requirements to "rapidly expand and strengthen the veterinary drug GMP enterprise sector" and "ensure the quality and effectiveness of veterinary drugs," our bureau has adhered to strengthening development awareness and regulatory awareness, balancing administrative licensing with daily supervision, and combining technical guidance with creating a favorable environment. We have undertaken several effective measures for veterinary drug GMP production and management.

　　I. Strengthen Organizational Leadership and Establish Work Mechanisms

　　Veterinary drugs are important agricultural production materials. The quality of veterinary drugs directly affects the sustained increase in efficiency of animal husbandry and the vital interests of farmers, the quality and safety of animal products and public health, the construction of the new socialist countryside, and the building of a harmonious society. Therefore, our bureau regards the supervision of veterinary drug GMP enterprises and ensuring their healthy and rapid development as a key task. Both the city and county-level agricultural and forestry departments have established and implemented a work mechanism where the director in charge takes personal responsibility and functional departments are specifically responsible. Veterinary drug administration work has been included as a major component of the annual performance evaluation for functional departments, serving as an important indicator for creating "civilized offices" and annual assessments.

　　II. Adhere to Daily Supervision to Ensure Standard Production

　　Based on the actual situation of the comprehensive abolition of local standards for veterinary products, the complete elimination of non-veterinary GMP enterprises, and the gradual introduction of national standard veterinary drugs, to effectively prevent illegal and irregular behavior by production enterprises and avoid various disharmonious factors and conflicts arising from the closure of non-veterinary GMP enterprises, our bureau has focused on three areas of work. First, the full implementation of the "informed consent" system. In accordance with the requirements of the "Zero Action Plan," we issued notices to ten non-veterinary GMP production enterprises requiring them to cease all production activities. We organized personnel from the drug administration management department and the agricultural and forestry administrative law enforcement department to conduct face-to-face briefings, promoting the spirit and requirements of the Ministry of Agriculture's Office "Notice on Strengthening the Post-Management Work of Veterinary Drug Production Enterprises That Have Not Passed GMP Inspection and Acceptance." We urged and assisted enterprises in carrying out ideological mobilization, employee placement, and workforce reallocation. We conducted a comprehensive inventory and registration of raw materials and products, with the enterprise legal representative signing a commitment on the notice. We also conducted on-site written notifications and inventory checks of products for four veterinary drug production enterprises that needed to stop producing related products due to the abolition of local standards. For the ten enterprises that have implemented veterinary drug GMP, in addition to issuing the "Wuxi City Veterinary Drug Production Enterprise Legal Operation Notice," we also prepared notices, in accordance with the spirit of Su Nong Mu [2005] No. 50, requiring strict adherence to the production scope specified in the veterinary drug GMP certificates and veterinary drug production licenses issued by the Ministry of Agriculture, prohibiting exceeding the production limits of veterinary drug products, and prohibiting the production of veterinary drugs in non-veterinary GMP workshops. The enterprise legal representative signed a commitment on the notice. Second, we conduct routine inspections every quarter. We focus on checking whether raw materials originate from legitimate enterprises and are legitimate products; whether production and testing are normal; whether the "informed content" has been implemented; and whether labeling is standardized. Third, we hold quarterly meetings with enterprise heads. We promptly convey the spirit and requirements of the Ministry and the province regarding drug administration work, report on various problems encountered during routine inspections, analyze the causes and solutions to these problems, exchange information on the enterprises' production and operation status and plans for the next quarter, and solicit opinions and suggestions from enterprises on the work of the drug administration department, implementing mutual supervision among enterprises.

　　III. Carry Out Market Regulation to Create a Development Environment

　　To prevent counterfeit and substandard veterinary drugs from impacting our city's GMP production enterprises and ensure that production enterprises have a good development environment, while strengthening daily supervision of the operation and use links, we organize three to four large-scale special rectification campaigns each year, primarily in the form of joint city and county-level actions. In 2006, our bureau organized four joint inspections, inspecting 157 livestock and poultry (aquatic) breeding bases and 347 veterinary drug business units. The inspection coverage of veterinary drug business units reached 88%, and the inspection coverage of livestock and poultry (aquatic) breeding bases reached 80%. We issued 74 decisions requiring rectification within a time limit and investigated 46 illegal units, including 17 cases that were investigated and prosecuted. At the same time, we significantly increased the sampling inspection of the quality of veterinary drug products and livestock (aquatic) products in the market. Through high-pressure market regulation, we have created a good development environment for veterinary drug production enterprises in our city.

　　IV. Strengthen Publicity and Training and Provide Comprehensive Services

　　First, provide information dissemination services. We consistently search the Ministry's and province's "Veterinary Drug Information Network" and the professional websites of related units such as industry and commerce and quality supervision two to three times a week, promptly providing enterprises with management dynamics and newly issued regulations and rules through the "Jiangnan Agricultural Network," and publishing the bureau's opinions and measures on implementing the spirit of higher-level directives. According to statistics, last year, the 29 related pieces of information released by the bureau on the "Jiangnan Agricultural Network" were viewed 3198 times. Second, provide technical training services. We consistently organize one to two training sessions each year for technical heads and quality inspection personnel of production enterprises, systematically studying the "Veterinary Drug Management Regulations," "Good Manufacturing Practice for Veterinary Drugs," and Ministry of Agriculture Announcements No. 426 and 560, as well as relevant business knowledge. Third, provide coordination and support services. We use activities such as "Safe Agricultural Inputs to the Countryside and Villages Publicity Week" and "Agricultural and Forestry Laws and Regulations Publicity Month" to provide enterprises with a platform to promote products, make public commitments, and have "zero-distance contact" with farmers. We leverage the advantages of the drug administration department to help enterprises achieve "production, learning, and research" integration and new product development, assisting enterprises in talent introduction and coordinating relationships between relevant departments. We use the activities of creating a "learning-oriented, innovation-oriented, and service-oriented" party branch to actively work with enterprise branches to promote the political theory study of enterprise party members and assist enterprises in continuously creating a good corporate culture and image.