Kexing Quality System Includes Kexing Drug Development And Production

QUALITY SYSTEM

Kexing Biopharm has established a quality system that complies with both Chinese and international standards. The system is systematically implemented throughout the entire process of drug development, production, sales, and use to achieve total quality management and continuous improvement. This ensures the safety, efficacy, and accessibility of drugs and continuously enhances drug quality.

GMP's Six Systems
Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Controls System.
Quality Policy
sound systems, honesty and trustworthiness, safety and efficacy, and continuous improvement.
Quality Goal
minimize the risks of contamination, cross-contamination, confusion and errors during drug production. By doing so, the Company ensures continuous and stable production of drugs that meet intended use and registration requirements.

Quality Management System
Taking Kexing Biopharm's development strategy as the fundamental guidance and the Drug Administration Law of the People's Republic of China, China GMP, EU cGMP and other relevant laws and regulations as well as the ICH guideline Q9 on quality risk management as the basis, the Company has established a quality management system to ensure continuous and stable production of drugs that meet intended use and registration requirements while avoiding risks in safety, efficacy, quality and regulations for itself and its patients. Meanwhile, the Company has also continuously improved its quality management system according to corporate culture, quality policy and goal, as well as GMP requirements. By doing so, all quality-related activities can be carried out on the basis of "rules and regulations," which lays a solid foundation for the Company's sales and market expansion activities.