Firmly promote the quality supervision of veterinary drugs

"We are diligent prison inmates. For the sake of epidemic prevention and control, and for the sake of safe homes, the sword of justice is clenched in our hands, inspecting, supervising, reviewing and reviewing scientific research, and escorting healthy farming!" The Song of the Central Supervision Office highly condenses the responsibility and mission shouldered by the China Institute of Veterinary Drug Supervision (hereinafter referred to as the Central Supervision Institute). As a national veterinary drug evaluation, inspection and supervision institution, the CIRC has always focused on the quality supervision of veterinary drugs, especially major animal disease vaccines, and made full use of flight inspection, supervision, inspection, batch issuance and other measures to ensure the quality and effective supply of major animal disease vaccines to meet the needs of animal disease prevention and control materials.

Focus on the supervision and inspection of vaccine quality around a center.

Under the guidance of the Veterinary Bureau of the Ministry of Agriculture, the central prison closely revolves around the central task of "quality supervision of vaccines for major animal diseases" and makes effective use of flight inspection as a form of supervision, while doing a good job in daily supervision, deploy and arrange together with the prevention and control of major animal diseases in spring and autumn, organize on-site quality supervision and inspection in spring and autumn to verify the immediate situation of quality management of veterinary drug production in enterprises. To standardize the production behavior of veterinary drugs and ensure the quality of veterinary drugs.

Highlight the pertinence. In 2015, in addition to conducting a comprehensive inspection of the implementation of veterinary drug GMP in various enterprises, two special inspections were organized to check the issuance and verification of the batch issuance of veterinary biological products and the implementation of the internal control quality standards of finished enterprises; to cooperate with the normative action of the Ministry of Agriculture on the labels and instructions of veterinary drug products, to check the implementation of product labels and instructions of enterprises producing animal biological products. Outstanding and forward-looking. "the lower limit of the quality of raw and auxiliary materials is the upper limit of the quality of vaccine products." in order to do a good job in vaccine quality, we need to start with raw and auxiliary materials. In view of the problems reflected in the supervision and inspection in recent years, the Central Supervision Institute moved the supervision gate forward, and when carrying out supervision and inspection, it took the quality control of the main raw and auxiliary materials as a special content, carried out inspection on SPF chicken embryos, serum, white oil and other important raw and auxiliary materials, and urged enterprises to further strengthen the quality control of raw and auxiliary materials to maximize the quality and safety of vaccines. Highlight the effectiveness. On the basis of a comprehensive analysis of the quality supervision situation of veterinary biological products, the Central Supervision Office formulates the inspection work plan scientifically and carries out the inspection by the combination of routine inspection and special inspection. Inspection according to the actual situation of enterprise production, some focus, a little faceted, a detailed understanding of vaccine production and quality control. Through the flight inspection in spring and autumn, we can achieve full coverage of major animal epidemic vaccine production enterprises; achieve full coverage of supervision and inspection of all animal biological products production enterprises within 3 years; achieve full coverage of supervision and inspection of unqualified production enterprises in the past three years.

Innovate the working mechanism and take a number of measures to ensure the quality of work

The object of quality supervision and inspection is mainly vaccine production enterprises, but there is no problem with the vaccine in the production process, does it mean that the vaccine used by farmers is qualified? In order to solve this problem, the CIRC starts with the circulation and use of products, increases the sampling links and changes the sampling methods. We will strengthen supervision over the procurement of major animal disease vaccines through government bidding, and increase the number of spot checks in circulation and use year by year. In 2015, 43 batches of samples were supervised and tested in circulation and use, accounting for 27% of all sampling batches of major animal disease vaccines, and the qualified rate of sampling in circulation and use was 93%. Enterprises need to obtain the product production license in accordance with the national standards for veterinary drugs, but the internal control standards higher than the national standards must be established during production to ensure that the quality index of the products leaving the factory is higher than the national standards. On the basis of this, the CIRC made an in-depth study of the relationship between the two, grasped the principal contradiction, adjusted the working mode of batch issuance, improved the implementation standard of product batch issuance, changed the national standard of veterinary drugs into the internal control quality standard of enterprise finished products, and achieved good results. By the end of November 2015, a total of 17287 batches of domestic product batch issuance reports had been reviewed and 17287 batches had been issued, with an issuance rate of 100 per cent. Among them, 5757 batches of major animal disease vaccines were issued and 5757 batches were issued, with an signing rate of 100%.

The middle prison organically combines flight inspection, supervision and sampling inspection, and batch issuance and other work, starting at one point, responding to the whole process, and effectively playing the role of 1: 1 > 2. Enterprises found to have unqualified records such as supervision and inspection shall carry out flight inspection in a timely manner; enterprises that have relatively serious problems before or during the flight inspection shall promptly supervise and inspect the products they produce. In 2015, 19 unqualified production enterprises of veterinary biological products were inspected by flight for nearly three years. The central prison has continuously improved the sampling inspection plans and programs for major animal disease vaccines, transferred decentralized testing in the past to centralized inspection, tested the same products produced by different enterprises at the same time, and controlled the influence of factors such as inspection process and experimental animals on the results, to ensure that the test results are scientific and fair. In 2015, a joint inspection was conducted on 5 varieties of bovine foot-and-mouth disease type An inactivated vaccine produced by four enterprises, with a qualified rate of 100%. In addition, the Central Commission of Supervision continued to step up the sampling inspection of illegal addition, increased the sampling inspection of veterinary drugs, and formulated nine standards, such as the detection method for illegal addition of lincomycin in Houttuynia cordata injection, which was announced by the Ministry of Agriculture.

The general mobilization of veterinary drug quality supervision has achieved practical results.

Before the start of the special inspection work for quality supervision, a mobilization training meeting shall be organized to clarify the tasks, key links, and specific requirements of flight inspection, and to strengthen the disciplinary requirements of standardized inspection, impartial inspection, and integrity inspection. The leaders personally led the team and took the lead, and the inspectors were all technical personnel who were selected from the expert database of veterinary drug GMP inspectors of the Ministry of Agriculture who had relevant work experience in veterinary biological products inspection and were competent for supervision tasks. In 2015, a total of 146 person-times from 56 flight inspection teams were sent to conduct centralized on-site inspections of 101 secondary animal biological products production enterprises in 27 provinces (municipalities and autonomous regions) across the country. As the leader of the inspection team, the leader personally led 33 people to inspect 42 enterprises. In order not to delay their own work and to complete the flight inspection task with quality and quantity, many inspectors silently sacrificed their rest time; some inspectors persisted in completing the flight inspection work in spite of their physical discomfort; because the flight inspection tasks had time limits, and some inspectors went back to Beijing on a business trip the day before, and went to the flight inspection enterprise the next day, working without complaint. "you can see it in ordinary times, you can rush it in critical times, and you can risk it in times of crisis." this is the true portrayal of veterinary drug GMP inspectors.

In 2015, the Ministry of Agriculture issued 330 batches of supervision and sampling inspection of veterinary biological products, and the Central Supervision Institute actually completed 335 batches of sampling inspection, involving 66 kinds of products from 72 enterprises (including agencies). The inspection passed 329 batches and 6 batches were unqualified, with a qualified rate of 98.2%, an increase of 1.2 percentage points over last year. In the whole year, 159 batches of major animal disease vaccines were sampled and tested, involving 20 products from 36 enterprises, including 30 batches of recombinant avian influenza H5 subtype inactivated vaccine, 29 batches of foot-and-mouth disease inactivated vaccine, 73 batches of highly pathogenic porcine reproductive and respiratory syndrome live vaccine, and 27 batches of special live classical swine fever vaccine procured by the government. The inspection was qualified in 155 batches and unqualified in 4 batches, with a qualified rate of 97.5%. 221 batches of veterinary drugs were tested, and the qualified rate was 71.9%, of which 28 batches were illegally added. Cooperate with the special rectification action of veterinary antimicrobials, organize the inspection and testing of relevant veterinary drugs, test 123 batches of antibiotics and 98 batches of qualified.

Over the years, the CIRC has constantly innovated the working mechanism for supervising the quality of major animal disease vaccines, adhering to good practices, absorbing good experience, and striving to ensure the quality, safety and effective supply of major animal disease vaccines. Achievements represent the past, and supervision is always on the way. As sung in the Song of the prison, "Science is fair, clean and efficient, and the people of the prison contribute silently; unite and cooperate, pioneer and innovate, and we will create new brilliance!"