Sinovac Beijing, the main operating subsidiary company of China based, Sinovac Biotech Ltd. has obtained Certificate of Good Manufacturing Practices for Pharmaceutical Products (GMP Certificate) from the State and Food Administration (FDA) for its proprietary vaccines, its Haidian district bulk production plants, and its Changping filing and packaging facility.
The GMP certificate covers Sinovac Beijing’s vaccines commercialized in China and approved for stockpiling, inclusive of hepatitis A vaccine (human diploid cell), inactivated; hepatitis A and B combined vaccine; influenza vaccine (split virion), inactivated; pandemic influenza vaccine (inactivated, adjuvanted); pandemic influenza vaccine (split virion,adjuvanted); H1N1 influenza A vaccine (Split Virion, inactivated) The GMP certificate is valid for five years starting from April 17, 2013.
New GMP standards were implemented in China by the CFDA in March 2011. These new standards are in line with international standards. According to the notice for the implementation of new GMP guidelines (2010 version) issued by CFDA in February 2011, all China-based vaccine manufacturers are required to pass the new GMP certification by the end of 2013.
In December 2012, the CFDA conducted a on-site inspection on Sinovac Beijing’s production plants in Haidian district and the new filling and packaging line in Changping district according to the Good Manufacturing Practice for Drugs (2010 Revision), the new GMP guidelines. The CFDA granted Sinovac the GMP Certification in April 2013 following the March 2013 public notification period.
Dr Weidong YIN, chairman, president and CEO, commented, “Sinovac Beijing’s vaccine products, its bulk production plants, and its Changping filling and packaging facility have passed the GMP inspection and received the GMP certificate under the new version of GMP guidelines ahead of the year end 2013 deadline. The GMP guidelines adopted in China in March 2011 are consistent with international standards.”
Sinovac Biotech Ltd. is a biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu) and mumps, as well as animal rabies vaccine for canines.