PCS conducted a comprehensive nine-day WHO GMP gap assessment at Yuxi Walvax Biotechnology in China. This assessment, carried out by three PCS consultants, aimed to prepare Walvax for an upcoming WHO prequalification audit covering several of its biotechnology products.
The project's objective was to assess Walvax's compliance with WHO GMP requirements, covering all aspects of quality assurance, manufacturing, testing, and storage. This assessment was crucial in providing insights into Walvax's current GMP compliance level and identifying areas for improvement before the WHO prequalification inspection, scheduled for the future.
The collaborative and transparent approach of Yuxi Walvax's staff and management greatly contributed to the success of the gap assessment. As a result, Yuxi Walvax has obtained WHO prequalification for several vaccines, including a COVID-19 vaccine.
Walvax holds a significant position in the pharmaceutical industry, evident from its partnerships and grants. The company has received three grants totaling US$ 8.5 million from the Bill & Melinda Gates Foundation. These grants support WHO prequalification for HPV2 and HPV9 vaccines, preparation for UNICEF procurement for Gavi countries, and expedited pre-clinical research for a Recombinant Subunit SARS-CoV-2 Vaccine.
Additionally, Walvax has partnered with CEPI and expanded collaboration to develop a COVID-19 multi-variant vaccine, receiving a grant of US$ 25.1 million. Moreover, HPV2 and MPV ACYW135 are undergoing WHO-PQ assessment, while PCV13 is in the preparation phase for WHO-PQ.
A WHO GMP gap assessment is invaluable for companies like Walvax seeking to expand their reach and elevate their quality standards. By identifying areas for enhancement and ensuring compliance with international regulations, such assessments pave the way for successful prequalification audits, bolstering the company's reputation and enabling broader access to life-saving vaccines and biotechnological products on a global scale.
