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Gap Assessment at Sinovac

PCS performed a WHO GMP gap assessment at Sinovac, Beijing, China.


Project summary

WHO GMP gap assessment at Sinovac to ready the organization for WHO prequalification.

Performing a WHO GMP gap assessment at Sinovac China to prepare Sinovac for WHO prequalification of it's vaccine products

To achieve WHO prequalification Sinovac wanted to get an understanding of it’s WHO GMP compliance status and the steps to take to get to WHO PQ. PCS was asked to perform a gap assessment of Sinovac’s facilities and quality system. The focus of the gap assessment was the vaccine production business unit.

The staff and management of Sinovac were extremely cooperative and transparent. This greatly attributed to the success of the gap assessment. Sinovac has achieved WHO prequalification for a number of it’s vaccines – including a COVID-19 vaccine.

PCS’ experience in vaccine manufacturing was highly beneficial during the GMP gap assessment. Over the past ten years PCS has been highly active in OPV, IPV and BSL-3 facilities.

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