Quality Control

We believe that “quality is the cornerstone of pharmaceutical development.” We implement rigorous quality control throughout the entire drug lifecycle and benchmark against the world’s most stringent quality standards to establish a closed-loop, end-to-end quality control system covering R&D, manufacturing, distribution, and post-marketing management. Our manufacturing facilities have obtained multiple internationally recognized GMP certifications from China, the European Union, PIC/S, and the U.S. FDA. Our quality management system has also garnered widespread recognition from pharmaceutical regulatory authorities in multiple countries.

We enforce stringent internal control criteria that exceed the requirements of international pharmacopoeias. Our quality testing laboratory has been selected as a Collaborative Calibration Laboratory for National Pharmaceutical Reference Standards by the National Institutes for Food and Drug Control. Having actively participated in the methodological optimization and validation for relevant monographs in the Chinese Pharmacopoeia, we have leveraged our expertise to elevate industry standards. Through a “zero-defect” quality culture embedded throughout the manufacturing process, we carry out tiered supplier evaluations and dynamic management, end-to-end GMP compliance, and real-time monitoring and continuous validation of critical process parameters, ensuring full traceability and stringent control across the entire value chain for every product batch.

We actively advance the digital transformation of quality management, leveraging intelligent systems to enable precise inspection and efficient multi-stakeholder collaboration. Meanwhile, we continuously provide company-wide quality training to strengthen quality awareness across the company, and integrate patient safety into institutional frameworks and operational procedures. In strict adherence to international pharmacovigilance standards, we have established a 24-hour adverse reaction monitoring system and a full-lifecycle risk management mechanism. Upholding world-class quality standards, we build an impregnable defense for medication safety and ensure the safe use of every biologic product.