Quality System

 

        Hepalink’s Quality Management system is world class.  Over 20% of the company’s employees are dedicated to Quality Management.  The company established a scientific, strict, comprehensive quality prevention and assurance system.


        All actions are controlled and traced according to China GMP, FDA’s cGMP and ICHQ7A, and European Regulations. The quality management system covers every aspect of the manufacturing and distribution process- raw material, storage, production, testing, logistics, validation and training, Hepalink’s quality system ensures the company can continuously supply Heparin Sodium API which meets current pharmacopeial and monographic quality requirements.