We have established a comprehensive quality management system that meets the quality standards of the US, EU and China, which lays the foundation to commercialise our products in multiple countries and regions. Our Xuhui Manufacturing Facility has passed multiple on-site inspections conducted by EU QP. The facility is in compliance with the current Good Manufacturing Practices (cGMP) standards. Particularly, the first product HLX01 (汉利康®, Rituximab Injection), was awarded the Certificate of Good Manufacturing Practices for Pharmaceutical Products, People’s Republic of China.
Our quality management system covers the entire product lifecycle, from research and development to material management, product manufacturing, quality control, product supply management and particularly, product post marketing surveillance. Managed by a team of overseas-trained experts with significant experience in pharmaceutical quality management, our Xuhui Manufacturing Facility and accompanying quality management systems have passed multiple on-site inspections and/or audits conducted by EU QP and our international commercial partners such as Accord and Cipla, in each case in accordance with exacting standards.
The Global Quality Operations department takes charge of our quality management system to ensure the realization of the standard and the execution of the system. We believe that this demonstrated commitment to quality management distinguishes us in the PRC market, highlighting our long-term dedication to providing patients worldwide with access to reliable and quality therapies.