Quality

There are 30 employees in Quality Dept., 20 of us are QC and 10 are QA. The number of licensed pharmacist or pharmacist is 12. The number of College or above is 21.We have always adhered to the policy of quality first, customer orientation and continuous improvement and the principle of “strengthen process management, create efficient mechanisms, strive for continuous improvement, the pursuit of excellence ”. Quality management covers all aspects of procurement of raw materials and packing materials, production, examination and release to ensure every link of product quality under control.

The area of QC Laboratory is 1,120m2 and it comprises instrument analysis lab, physical-chemical analysis lab and microbe examination lab. QC laboratory mainly engages in analysis of materials, intermediate and APIs throughout the whole production, and be equipped with advanced instruments such as Agilent HPLC, GC, Nicolet iS5 IR, Malvern Granulometer and et. al.

Total 8 APIs have been issued new version GMP certificate. We were awarded “AAA credit enterprise” by Changzhou FDA in last five consecutive years. Valacyclovir hydrochloride, Ganciclovir and Ciclopirox Olamine have passed the Mexican authority GMP inspection on October 2014; Famciclovir has passed KFDA GMP inspection on April 2015; Our quality management system has passed the US FDA inspection on July 2016, and earn favourable comment from investigator.