Friday, 3 January 2014

China's top 3 hepatitis B vaccine makers ordered to stop production because of GMP failings

by Michael Woodhead
China's three major manufacturers of hepatitis B vaccine have been ordered to suspend production because they have failed to meet new stringent GMP criteria that came into effect in 1 January.
The order from the Chinese Food and Drug Administration (SFDA) applies to Shanzhen Biokangtai, whose hepatitis B vaccine has been linked to a string of deaths among newborns in recent weeks. It also applies to Dalian Hanxin and Tiantan Biologicals.
According to a report from Xinhua, the vaccine manufacturers knew in advance that they had to meet the new GMP criteria by 1 January but failed to do so. The report says the new GMP criteria apply to all aseptic manufacturing plants, of which there are 1319 in China. It says two thirds have already met the new GMP requirements and others are working towards them. However, the three hepatitis B vaccine manufatcurers have not met the criteria and have been told that any further products produced from 1 January will not be accepted for use in China.
The Xinhua report notes that the three manufacturers account for about 80% of hepatitis B vaccine producetion in China. other manufacturers such as Hualan and Huabei have achieved GMP licencing but produce only about 10% of the vaccine supplies.
The SFDA says new GMP criteria apply to all manufacturers, and they estimate that there are GMP-compliant manufacturers for all 171 essential medicines. Mannufacturers who have not yet met the criteria have stockplied supplies of essential medicines, Xinhua notes.
The SFDA empahises that the move is only a temporary suspension of manufacturing and it is not ordering the  manufacturers to shut down the production facilities. Production may be resumed once the manufacturers show they are meeting GMP requirement, the SFDA says.

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