Solid Progress in Veterinary Drug Quality Supervision
"We are diligent people of the China Institute of Veterinary Drug Control; for disease prevention and control, for a safe homeland, the sword of justice is held firmly in our hands; testing, supervision, review and research, escorting healthy breeding!" The "Song of the China Institute of Veterinary Drug Control" highly distills the responsibility and mission shouldered by the China Institute of Veterinary Drug Control (abbreviated as the Institute). As a national-level veterinary drug review, testing and supervision institution, the Institute has always taken the quality supervision of veterinary drugs, especially vaccines for major animal diseases, as the focus of its work, making full use of multiple measures such as flying inspections, supervisory testing and batch release, with efficient coordination, to spare no effort in safeguarding the quality and effective supply of vaccines for major animal diseases and to meet the material needs of animal disease prevention and control.
Focusing on one central task, doing a good job in vaccine quality supervision and inspection
Under the guidance of the Veterinary Bureau of the Ministry of Agriculture, the Institute closely focuses on the central task of "quality supervision of vaccines for major animal diseases", effectively utilizing the regulatory form of flying inspections, and while doing a good job in routine supervision, deploys and arranges them together with the national spring and autumn prevention and control of major animal diseases, organizing centralized on-site quality supervision inspections in two concentrated sessions in spring and autumn, verifying the immediate status of enterprises in terms of veterinary drug production quality management, so as to standardize veterinary drug production behavior and ensure veterinary drug quality.
Highlighting targetedness. In 2015, in addition to conducting comprehensive inspections of each enterprise's implementation of veterinary drug GMP, 2 special inspections were also organized to inspect the implementation of finished-product enterprises' internal control quality standards in the batch release review of veterinary biological products; in conjunction with the Ministry of Agriculture's action to standardize veterinary drug product labels and instructions, inspections were conducted on the implementation of product label and instruction requirements by each veterinary biological product manufacturing enterprise. Highlighting forward-lookingness. "The lower limit of raw and auxiliary material quality is the upper limit of finished vaccine quality." To do a good job in vaccine quality work, one must start with raw and auxiliary materials. In response to problems reflected in supervision and inspection in recent years, the Institute moved the regulatory threshold forward, and when implementing supervision and inspection, made the quality control of main raw and auxiliary materials a special item, carrying out inspections on important raw and auxiliary materials such as SPF chicken embryos, serum and white oil, urging enterprises to further strengthen raw and auxiliary material quality control and maximize the guarantee of vaccine quality and safety. Highlighting effectiveness. On the basis of comprehensively analyzing the situation of quality supervision of veterinary biological products, the Institute scientifically formulated inspection work plans and carried out inspections by combining routine inspections with special inspections. During inspections, according to the actual production situation of enterprises, emphasis was placed appropriately, covering both key points and broad areas, to understand in detail vaccine production and quality control. Through spring and autumn flying inspections, full coverage of vaccine manufacturing enterprises for major animal diseases was achieved; full coverage of supervision and inspection of all veterinary biological product manufacturing enterprises within 3 years was achieved; and full coverage of supervision and inspection of manufacturing enterprises that failed supervisory sampling in the past 3 years was achieved.
Innovating working mechanisms and ensuring work quality through multiple measures
The targets of quality supervision and inspection are mainly vaccine manufacturing enterprises, but if there are no problems with vaccines at the production stage, does that mean the vaccines used by breeders are qualified? To solve this problem, the Institute started from the product circulation and use stages, increased sampling stages and changed sampling methods. It strengthened supervision of vaccines for major animal diseases purchased through government bidding, and increased year by year the number of samples taken in circulation and use stages. In 2015, 43 batches were sampled for supervisory testing in circulation and use stages, accounting for 27% of all sampled batches of vaccines for major animal diseases, and the qualification rate of sampling in circulation and use stages was 93%. Enterprises need to obtain product production licenses in accordance with national veterinary drug standards, but during production they must establish enterprise internal control standards higher than national standards, ensuring that quality indicators at the time of product release are higher than national standards. Accordingly, the Institute studied the relationship between the two in depth, grasped the main contradiction, adjusted the working method at the batch release stage, raised the standard implemented for product batch release, and changed the national veterinary drug standard to the enterprise finished-product internal control quality standard, achieving relatively good results. As of the end of November 2015, a total of 17,287 batches of domestic product batch release reports had been reviewed and 17,287 batches had been released, with a release rate of 100%. Among them, 5,757 batches were vaccines for major animal diseases, and 5,757 batches were released, with a release rate of 100%.
The Institute organically combines multiple tasks such as flying inspections, supervisory sampling and batch release linkage; once one point is activated, the whole process responds, effectively giving play to the role of 1+1>2. For enterprises found to have records of supervisory testing failure, flying inspections are promptly implemented; for enterprises found before or during flying inspections to have relatively serious problems, products they manufacture are promptly sampled for supervisory testing. In 2015, flying inspections were conducted on 19 enterprise-instances of veterinary biological product manufacturing enterprises that had failed supervisory sampling in the past 3 years. The Institute continuously improved the sampling plans and schemes for vaccines for major animal diseases, transitioning from past decentralized testing to centralized joint testing, simultaneously testing the same type of product produced by different enterprises, controlling the influence of factors such as the testing process and experimental animals on results, and ensuring that testing results are scientific and fair. In 2015, joint testing was organized for bovine foot-and-mouth disease type A inactivated vaccines of 5 varieties produced by 4 enterprises, with a qualification rate of 100%. In addition, the Institute continued to increase sampling intensity for illegal additions and increased baseline sampling work for veterinary drugs, formulating 9 standards including the method for testing illegally added lincomycin in Houttuynia cordata injection, which were announced and issued by the Ministry of Agriculture.
Full mobilization, and veterinary drug quality supervision work achieved practical results
Before the special quality supervision and inspection work began, a mobilization and training meeting was organized to clarify the work tasks, key links and specific requirements of flying inspections, and to strengthen the disciplinary requirements for standardized inspection, fair inspection and clean inspection. Institute leaders personally led teams and took the lead, and inspectors were all technical personnel selected from the Ministry of Agriculture veterinary drug GMP inspector expert pool who had work experience related to veterinary biological product testing and were competent for supervision tasks. In 2015, a total of 56 flying inspection teams and 146 person-times were dispatched, and centralized on-site inspections were conducted on 101 enterprise-instances of veterinary biological product manufacturing enterprises in 27 provinces (municipalities and autonomous regions) across the country. Among them, Institute leaders, as team leaders, personally led 33 person-times and inspected 42 enterprise-instances. In order not to delay their regular work while still completing flying inspection tasks with quality and quantity guaranteed, many inspectors silently sacrificed their own rest time; some inspectors, despite physical discomfort, still persisted in completing flying inspection work while ill; because flying inspection tasks all had time limits, some inspectors had just returned to Beijing from a business trip the previous day and set off again the next day to flying inspection enterprises, bearing hardship without complaint and never grumbling. "Visible in ordinary times, able to charge forward in key times, able to step forward in moments of crisis" is a true portrayal of veterinary drug GMP inspectors.
In 2015, the Ministry of Agriculture issued a supervisory sampling plan task of 330 batches of veterinary biological products; the Institute actually completed 335 sampled batches, involving 66 products from 72 enterprises (including agencies). 329 batches passed inspection, 6 batches failed, and the qualification rate was 98.2%, 1.2 percentage points higher than last year. Over the year, 159 batches of vaccines for major animal diseases were sampled, 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 swine fever live vaccine specially for government procurement. 155 batches passed inspection, 4 batches failed, and the qualification rate was 97.5%. For veterinary drug testing, 221 batches were tested, with a qualification rate of 71.9%, among which 28 unqualified batches involved illegal additions. In cooperation with the special rectification action on veterinary antibacterial drugs, testing and detection of relevant veterinary drugs were organized, and 123 batches of antibacterial drugs were tested, with 98 batches qualified.
For many years, the Institute has continuously innovated the quality supervision working mechanism for vaccines for major animal diseases, persisted in good practices, absorbed good experience, and strived to ensure the quality safety and effective supply of vaccines for major animal diseases. Achievements represent the past, and supervision is always on the road. Just as the "Song of the China Institute of Veterinary Drug Control" sings: "Scientific and fair, clean and efficient, the people of the Institute quietly dedicate themselves; united and cooperative, pioneering and innovative, we will cast new glory again!"