1、Quality
system framing
We had established a drug intermediates produce quality management system accordingly with the ICHQ7, which is independent of produce department on duty of QA and QC.
2、Quality Policy
Customer Satisfy, Consistent Quality, Duty of Everyone, Continuous Improvement
Quality control system
3、The quality control system is divided into 6 departments same as FDA: Quality System, Produce System, Equipment System, Material System, Package System and Research System. We had SOP and complete training process for each system.
4、Quality control mode
PDCA is used as our daily work quality control mode.
5、Customer audit
We has passed 7 audit form our customer contain KOLON LIFE SCIENCE, INC and SCI PHARMTECH, INC.
No big defect found.