According to the unified deployment of our ministry, the local organizations have completed the quality supervision sampling inspection plan for veterinary drugs (excluding veterinary biological products) in the second quarter of 2010, and now report the sampling inspection as follows:
1. Basic information
In the second quarter, there were 3510 batches of veterinary drug legal enterprise products confirmed and 3213 batches of qualified products, with a pass rate of 91.5%, a decrease of 0.4 percentage points from the first quarter of 2010 (Annex 1-1, Annex 1-2). Among them, 792 batches were evaluated for random sampling in this quarter, 746 batches were qualified, and the pass rate was 94.2% (Annex 2); 1738 batches were monitored for random checks, 1582 batches were passed, and the pass rate was 91.0%; 566 batches were tracked and sampled, 498 batches were passed, pass rate 88.0%; 414 batches were randomly selected and 387 batches were qualified, with a pass rate of 93.5%.
In the second quarter, 1056 batches were sampled from the production link, and 1019 batches were qualified, with a pass rate of 96.5%, a decrease of 2.1 percentage points from the first quarter of 2010 (98.6%); 1925 batches were sampled from the operating link, 1705 batches were qualified, and the pass rate was 88.6%, compared with The first quarter of 2010 (89.7%) decreased by 1.1 percentage points; 529 batches were checked for use and 489 batches were qualified, with a pass rate of 92.4%, an increase of 0.7 percentage points from the first quarter of 2010 (91.7%). Among them, 127 batches of veterinary drugs for aquatic products were sampled, 116 batches were qualified, and the pass rate was 91.3%; 4 batches of veterinary drugs for bee samples were sampled, and 3 batches were qualified.
From the perspective of sampling product categories, 1877 batches of chemical products were sampled and 1747 batches were qualified, with a pass rate of 93.1%, a decrease of 2.0 percentage points from the first quarter of 2010 (95.1%); antibiotics products were sampled for 747 batches and qualified 692 batches, with a pass rate of 92.6%, an increase of 1.0 percentage point from the first quarter of 2010 (91.6%); 865 batches of Chinese medicine products were sampled, 754 batches were qualified, and the pass rate was 87.2%, compared with the first quarter of 2010 ( 87.0%) The qualification rate increased by 0.2 percentage points; 21 batches of other products were sampled and 20 batches were qualified. The qualification rate was 95.2%, which was 4.8 percentage points lower than the first quarter of 2010 (100%). According to the principle of division of key monitoring enterprises, it was determined that Shijiazhuang Luancheng Xinyu Pharmaceutical Co., Ltd. (five batches failed); Chongqing Zhongya Animal Pharmaceutical Co., Ltd. (two batches of illegal drugs added); Jiangxi Chuangxin Animal Pharmaceutical Co., Ltd. Three companies including the company (three batches containing less than 80%) are key monitoring companies. Information on qualified products for random inspections in the second quarter can be found on the "Chinese Veterinary Drug Information Website".
(1) Organize the liquidation of fake and inferior veterinary drugs. All localities shall immediately organize the collection and destruction of the fake and inferior veterinary drugs listed in Annexes 1-1 and 1-2 of this notification, and organize verification to carry out punishment for illegal production and operation enterprises and users according to law.
(2) Strengthen the GMP supervision of veterinary drugs. All localities should carry out supervision and inspection of the implementation status of the veterinary drug GMP listed in the notified enterprise in combination with the veterinary drug market rectification activities, and find that violations and violations must be investigated and dealt with according to law. Provincial and municipal veterinary authorities in Hebei, Jiangxi, Chongqing and other provinces should organize the investigation and handling of key monitoring enterprises in accordance with the law and include them in their daily supervision priorities.
(3) Strengthen veterinary drug regulatory measures. First, for products of the same variety that fail to pass two consecutive random inspections, the product approval number shall be revoked according to law, and the application for approval of the product approval number shall not be accepted within one year; second, for enterprises that have been included in key monitoring twice during the year In accordance with the law, administrative punishment measures such as withdrawing the "Veterinary Drug GMP Certificate" or revoking the "Veterinary Drug Production License" and the approval number of the veterinary drug product are taken, and all applications for administrative licensing of veterinary drugs by the enterprise will not be accepted within one year. After the enterprise accepts the administrative punishment, it will resume accepting the application for veterinary drug administrative license declaration; the third is that for the enterprises that have been included in the key monitoring during the year, the provincial veterinary competent department has not completed the case investigation, submitted the enterprise rectification report, and did not submit the fake and inferior veterinary drugs Prior to the destruction of records, GMP inspection and acceptance of veterinary drugs will not be arranged for the time being, and applications for administrative licenses such as production licenses for veterinary drugs and product approval numbers will not be accepted.