SinoBiomed facility gets GMP certification from SFDA
Chinese State Food and Drug Administration (SFDA) has recertified Shanghai Wanxing Bio-pharmaceuticalsâ€™ recombinant human interferon production plant as a Good Manufacturing Practice (GMP) facility. Shanghai Wanxing Bio-pharmaceuticals is a 82 percent owned subsidiary of China-based SinoBiomed.
The 2,500 sq mt plant passed the local GMP re-certification inspection that the SFDA conducted from April 12 to 14, 2007 in Shanghai. The facility produces recombinant human interferon powder for injection. Recombinant human interferon is widely used for treating chronic hepatitis B, hepatitis C, a number of viral infections, and tumors.
In meeting Chinese national drug GMP certification standards, the plant's heating ventilation air conditioning system achieved a grade of 100 in the SFDAâ€™s air cleanliness classification, equivalent to a B grade in the US air cleanliness classification.
The facility has one of China's largest production capacities and has produced some 12 million doses of recombinant human interferon since its initial five-year certification on December 12, 2001. The recertification authorizes production for another five-year term, ensuring quality control for the product as Shanghai Wanxing expands national and international distribution.... more