In pharmaceutical manufacturing, quality is not the responsibility of one department—it is the shared lifeline that runs through every link of our value chain. The Quality Department stands as both the vigilant guardian of this lifeline and the vital connector across functions. Only through seamless collaboration among Production, R&D, Procurement, Sales, and beyond can we build an unbreakable foundation of quality—fulfilling our industry’s highest calling and demonstrating our corporate commitment.

From the very moment raw materials enter our facility, the Quality Department enforces rigorous standards, conducting thorough supplier qualification reviews and material inspections to ensure no non-conforming materials ever enter the production process. During manufacturing, the Production Department strictly adheres to GMP guidelines, Ｅxecuting standardized procedures and meticulously documenting all critical process parameters in real time. Simultaneously, the Quality Department implements end-to-end compliance monitoring—from real-time verification of process parameters and environmental monitoring of cleanliness conditions to on-site supervision of operator compliance. At every critical control point, a dual-verification mechanism is jointly established with Production, forming a closed-loop management system of “Production Ｅxecution-Quality Oversight-Concurrent Review.”This ensures standardization and full traceability throughout the manufacturing process. By jointly focusing on Critical Quality Attributes (CQAs), both departments maintain real-time communication and rapid response capabilities to proactively identify, assess, and resolve potential risks—laying a solid quality foundation for downstream operations. At the final product release stage, every batch undergoes stringent quality evaluation. Release certificates are issued only when all specifications fully comply with pharmacopoeia standards, customer requirements, and applicable domestic and international regulatory regulations.

In 2025, under the strategic guidance of the company and through seamless cross-departmental collaboration, we successfully hosted approximately 60 customer audits and site visits, completed 10 official regulatory inspections, and conducted 4 internal audits independently. As a result, we achieved major milestones: successful certification by Japan PMDA and the U.S. FDA once again; market authorization granted for Moxifloxacin Hydrochloride Eye Drops, for which our company acts as the Marketing Authorization Holder (MAH); and successful compliance inspections for key products such as Diosmin. Additionally, we completed re-registration for several priority products- including Artificial Cow-bezoar, Indigo Naturalis, Inositol, Asparagine, and Capecitabine, securing continued market access and uninterrupted supply. These accomplishments underscore the power of integrated teamwork and validate the scientific rigor and forward-looking nature of our quality management philosophy.

Quality demands vigilance; compliance admits no shortcuts. The unique nature of the pharmaceutical industry demands that we approach every detail with the utmost caution, as if “walking on thin ice”and address every potential quality issue with zero tolerance. The Quality Department remains steadfast in its mission: guided by a robust quality management system and a commitment to rigor, we stand shoulder to shoulder with R&D, Production, Procurement, Sales, and all other functions. Together, we continuously refine quality control processes, strengthen risk early-warning mechanisms, and enhance the efficiency of quality issue resolution, to build an unwavering defense for the safety and integrity of our APIs

Looking ahead, the Quality Department will continue to anchor all activities in GMP principles and uphold data integrity as an inviolable baseline. We are committed to relentlessly improving our quality assurance system, holding ourselves to ever-higher standards, and advancing our capabilities in quality oversight and compliance governance.