Sinovac Receives Updated cGMP Accreditation from CFDA

By Dan Stanton contact

- Last updated on GMT

Related tags: Influenza, Influenza vaccine, Influenza pandemic

Sinovac Receives Updated cGMP Accreditation from CFDA
Vaccine manufacturer Sinovac has updated its GMP accreditation to international standards, short of the deadline set by the CFDA.

Sinovac Beijing - a subsidiary of Sinovac Biotech – had an inspection by China’s Food and Drug Administration (CFDA – previously known as the SFDA) last December and the company has announced that both its manufacturing facility in the Haidian District of Beijing and its Changping filing and packaging facility have received Good Manufacturing Practices (GMP) accreditation.

According to Aaron Estrada, a representative of the firm, the company manufactures vaccines for hepatitis and influenza that are approved for sale in China and for stock piling by the Chinese Goverment.

“With the GMP certification from the CFDA, Sinovac will continue to manufacture and sell its vaccines in China,”​ said Estrada to in-Pharmatechnologist.com.

In 2010 the company was one of two selected by the Chinese Government to supply a hepatitis A vaccine​ as part of its immunisation programme. The Beijing Centre for Disease Control and Prevention chose Sinovac to supply approximately 477,000 doses.

According to a press release, the company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program

International GMP Standards

The accreditation – which is valid for five years – will also add to China’s current Vaccine Supply System Development Plan​, a move towards self-reliance in meeting the nation’s vaccine needs.

As one of several measures to strengthen home-grown production capabilities, the cGMP standards within China were reformed in March 2011​ in order to fall in line with international standards. A deadline of end of 2013 was given for manufacturers to adapt to the new standards.

The changes were intended to raise quality standards and attract expatriates back to China to bolster the workforce, especially as – a report by property firm Jones Lang LaSalle said in 2011 - China’s cost advantages had began to be eroded by wage increases, currency appreciations and inflation.

As well as China, Sinovac also supplies vaccines to countries including Nepal, Mexico and the Phillipines.

Related topics: Processing, Regulatory & Safety, QA/QC

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