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Overall quality of China's blood products good, Chinese spokeswoman
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17:31, September 11, 2007

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The overall situation of China's blood products and vaccine manufacturers is good and product quality is guaranteed, according to China's food and drug watchdog.

Yan Jiangying, spokeswoman of the State Food and Drug Administration (SFDA), made the announcement at a regular press conference to brief reporters on the results of two special investigations into China's blood products.

The SFDA sent 14 inspection teams to investigate 29 blood product manufacturers from April to May in 2007 and 12 inspection teams to investigate 29 vaccine manufacturers in June, Yan said.

"During the investigations, we found no serious violation of laws or regulations and most manufacturers have strictly abided by the good manufacturing practice and tried to improve the quality of their products," she said.

However, Yan admitted that problems existed. A shortage of human albumin was the most serious issue and investigations found that some blood companies still used outdated equipment during the production process.

"Although the SFDA is mainly responsible for the supervision of product quality, the SFDA will try to work with the Ministry of Health to solve this issue," Yan said.

Yan also said the quality of managers should be further enhanced and administration of some companies needed to be strengthened.

China has tried to strengthen its supervision of pharmaceutical and biological products this year. In July, the SFDA revoked the production license of Guangdong Baiyi Pharmaceutical Company after it made blood products from an infected donor. The antibodies of some patients injected with the blood tested positive for hepatitis C.

Yan said after the Baiyi incident the National Institute for the Control of Pharmaceutical and Biological Products tested for the hepatitis C virus and AIDS antibody in 480 batches of blood products made by 29 companies.

"All the products were qualified and the samples were negative, " Yan said.

Source: Xinhua

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