Guangdong Bioyee Pharmaceutical Company and Hainan Kangliyuan Pharm Company have been punished for violating related provisions in China's Good Manufacture Practices and their GMP licenses have been revoked.
China's State Food and Drug Administration says the two companies have been punished after a GMP audit in December 2006 revealed problems. SFDA has asked these two companies to recall related medicines and for the Guangdong Provincial Food and Drug Administration to further investigate the issue.
Bioyee is a pharmaceutical company which produces blood products, and Kangliyuan is a manufacturer of freeze dried powder for injections, capsules, pills and other raw materials for manufacturing medicine.
During 2006, SFDA conducted audits on 24 pharmaceutical manufacturers, and the GMP certificates of 13 of those companies were revoked, nine companies were asked to make changes, and two others were put under investigation.
In 1998, China's State Drug Administration first decided that all pharmaceutical manufacturers must meet GMP standards and obtain GMP certification before June 30, 2004. They then reissued the GMP regulations in 1999. In April 2003, SDA was renamed the State Food and Drug Administration. Although SFDA authorized provincial drug administrations to accelerate GMP examination in 2002, only about 3800 of the previous 6400 pharmaceutical manufacturers met GMP regulations as of July 1, 2005.
