Vaccine quality evaluation of different standards will be listed after the start - the vaccine - the pharmaceutical industries

in Vaccine

The number of vaccine manufacturers in China more than technology differences, product quality is also uneven. To ensure vaccine quality, China will gradually start the market re-evaluation. Experts also recommended that vaccine manufacturers to strengthen bio-security monitoring, management practices and systems to establish and monitor the implementation of the whole production process.

Vaccine incident in Shanxi issue of great concern by the whole society, although this event has not yet conclusive, but the vaccine quality and safety of the vaccine has attracted unprecedented attention. Disease control departments have expressed around the vaccine itself is safe, but some parents in the future should the issue of vaccination for children is more hesitant.

In fact, before the scandal was revealed, the quality of vaccines and bio-safety control problem has been mentioned experts put forward.

Vaccine quality standards to be improved

China CDC director Wang Yu, said recently that the vaccine currently used in China are mostly immune from the requirements of the State in accordance with the plan funded by the Government to immunize people who need pure public good products, but some vaccine production Enterprise technology has lagged behind, the lack of funding and conditions to be improved, and regulators are also listed the lack of these vaccines after a large-scale systematic reviews. Biological Co., Ltd. Liaoning Cheng Kung University

Zhang Xiaohua, deputy general manager of "substandard quality of some vaccines," the statement has a different view. She told reporters that the so-called vaccine quality is substandard in some major production of the vaccine, compared with the highest international standards there is a gap, does not mean inferior quality of domestic vaccine products.

It is understood that most of our varieties have vaccine production technology and international trends, such as Bio Co., Ltd. Liaoning Cheng Kung University bioreactor technology to produce the rabies vaccine and Japanese encephalitis vaccines, Beijing Sinovac Biotech Company Limited by cell factory technology to produce the vaccine, Dalian High-tech bio- Pharmacy Limited use of Hansenula genetic engineering technology to produce the hepatitis B vaccine and other products, the indicators have reached international advanced level. The current problem is that many Chinese vaccine manufacturers, large differences in technology, product quality is uneven.

To ensure vaccine quality, the implementation of the vaccine batch release system for our country, that is mandatory for each batch of vaccine be listed after passing inspection Sell . Zhang Xiaohua introduced the batch release of the reference standard is the company's registration standards, as long as the registration standards higher than the national minimum standards, companies will be allowed to produce vaccines. However, the company's registration criteria are different, although the batch release are qualified products, quality or differences in.

The trade, financial pressure because of other reasons, the provinces in the vaccine Tender Procurement, when the share price factors in the weight of the tender is higher, especially some economically less developed areas of financial difficulties, leading to high costs, quality and advanced products at a competitive disadvantage. This is part of our use of the vaccine product quality falls short of international standards the main reason.

Improve monitoring standards and requirements China Drugs Vaccine and Biological Products of Its director has expressed the hope that China's relevant departments and sectors of production and quality control of biological products, bio-security issues have increased in importance. "Because the vaccine production process involves many kinds of pathogenic microorganisms, the production scale, complex production process, equipment, facilities and more, while its scope of work involved in microbiology, immunology and animal science and other fields, how to ensure that vaccine manufacturers of bio-security the establishment of bio-security specification is currently a serious problem in China. "

Kingdom of governance suggest that "pathogenic microbiology laboratory biosafety regulations" in the biological safety-related requirements included in the new Good Manufacturing Practices (GMP), the clear classification of pathogenic microorganisms in animal experiments, the increase in bio-security-related content. Enterprises should set up bio-security risk assessment system, production and quality control of biological products, the potential exists to identify risks and propose preventive measures and risk re-evaluation. Regulators should be in accordance with national standards on biosafety new requirements, compliance verification workshop production of biological safety requirements, plus Johnson Material products manufacturer training practitioners of biological safety knowledge. Meanwhile, relevant departments should strengthen the pathogenic microorganisms involved in the biological safety of biological products, and establishing conditions for vaccine manufacturers in China biosafety specifications.

Zhang Xiaohua, monitor production process made the proposal. "And the different chemical, biological drugs, product quality is closely related with the entire production process." There are many international pollution because of the production process, not completely attenuated, virus-free method is not correct, strictly control the production process caused by the vaccine safety accident, therefore, to eradicate vaccine safety incidents, production process monitoring is essential.

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Vaccine quality evaluation of different standards will be listed after the start - the vaccine - the pharmaceutical industries

This article was published on 2010/09/20