Sinovac Biotech, Ltd., receives GMP certificate reflecting new standards
The GMP standards were raised in March 2011 by the CFDA. These new standards reflected international vaccine manufacturing standards, and require all manufacturers of vaccines to pass the new GMP certification by the end of the 2013 calendar year.
The new certificate for Sinovac approved the Beijing-based provider for the stockpiling of vaccines, including the inactivated hepatitis A vaccine, hepatitis A and B combined vaccine, inactivated split virion influenza vaccine, inactivated pandemic influenza vaccine and H1N1 influenza A vaccine. The certificate will be good for five years, ending on April 17, 2018.
The process for Sinovac's approval began with an on-site inspection of the facility in December 2012. The filing and packing lines had to be redesigned to adhere to the new GMP guidelines. Once the public was notified in March, Sinovac received its certification in April.
"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," President, CEO and Chairman of Sinovac Dr. Weidong Yin said. "The GMP guidelines adopted in China in March 2011 are consistent with international standards."