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Rated 4.55 of 5

Gap Assessment at Yuxi Walvax Biotechnology

PCS performed a WHO GMP gap assessment at Yuxi Walvax Biotechnology (China).


Project summary

WHO GMP gap assessment for nine days at Yuxi Wlvax China, helping Walvax prepare for a WHO prequalification audit.

Performing a nine-day WHO GMP gap assessment at Yuxi Walvax Biotechnology in China. The gap assessment was performed by three consultants of PCS to prepare Walvax for an upcoming WHO prequalification audit of a number of Walvax's biotechnology products.

PCS was asked to perform an extensive gap assessment against the WHO GMP requirements to get an understanding of the WHO GMP compliance level. The project was requested in light of an upcoming WHO prequalification inspection in the distant future. All aspects of Quality Assurance, manufacturing, testing and storage were assessed. At the conclusion of the nine-day gap assessment the auditors presented a WHO GMP gap report.

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

Walvax has received three grants worth US$ 8.5 million in total from the Bill & Melinda Gates Foundation to support WHO prequalification for the HPV2 and HPV9 in order to prepare for UNICEF procurement for Gavi countries, and to expedite pre-clinical research of Recombinant Subunit SARS-CoV-2 Vaccine as well. Walvax has also partnered with CEPI and expanded collaboration to develop COVID-19 multi-variant vaccine, with a total of US$ 25.1 million grant being received. In addition, HPV2 and MPV ACYW135 are under WHO-PQ assessment, while PCV13 is undergoing WHO-PQ preparations.

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