Chengda Biological Crazy Seedling Workshop All Passed the New GMP Certification


Release date: 2015-07-13 15:58:33.000

Visits:

The two crazy seedling production workshops of Chengda Biology are respectively in2012Year12month and2014Year3The month passed a new edition.GMPCertification. At this point, Chengda Biology has resumed its annual production.1000Ten thousand people use the ability of crazy seedlings. According to data from the State Food and Drug Administration, the existing8Family rabies vaccine manufacturer passes new versionGMPCertification, whereVeroCell5Home, Hamster Kidney Cell2Home, Human Diploid Cell1Home. Another nearly 40% of the crazy seedling enterprises have not passed the certification and have suspended production.

 

Reviewing the history of the market, the continuous improvement of national standards and the strict supervision of government departments have promoted the continuous upgrading of product quality.

 

In order to improve the immune effect of rabies vaccine, the State Food and Drug Administration has been2004Since the year, enterprises have been promoted to develop adjuvant-free vaccines so that patients can be effectively protected as soon as possible.2005Year9The batch issuance of adjuvant rabies vaccine was stopped in January, which promoted the upgrading of enterprises. The adjuvant-free rabies vaccine, which is characterized by rapid production of protective antibodies and few adverse reactions such as local induration, has been widely used, and the quality of rabies vaccine has reached a new level.2005Year8The monthly human rabies vaccine is included in the batch issuance management, and each batch of ex-factory or imported vaccines is subject to mandatory inspection and review. Those who fail the inspection or are not approved shall not be listed or imported.2006Year12In January, the production of rabies vaccine was specially controlled for half a year, which effectively curbed illegal acts such as applying batch numbers and further standardized the market.

 

 

201010The implementation of the new Pharmacopoeia has further improved the effectiveness and safety of rabies vaccine, and the improvement of the main index standards has once again blocked the entry of substandard vaccines into the market. The number of enterprises approved for issuance in 2011 decreased from 15 in 2008 to 10. At the same time, the number of enterprises using bioreactor process to produce rabies vaccine on a large scale has gradually increased, which has promoted the technological progress from the traditional rotary bottle process to the advanced reactor process.

 

With the widespread use of high-quality rabies vaccines represented by Chengda Suda, the epidemic situation of rabies is declining year by year. In 2013, the number of cases in the whole year was only 1172, a new low since the 21st century.