QC
The company owns a 410m2 class C QC laboratory, including sections for physical and chemical analysis, instrument analysis, microbiological testing and stability testing.
The analytical equipments include HPLC, GC, IR, UV, Laser particle size analyzer and other calibrated equipments/instruments, which can meet the inspection requirements for raw materials, packaging materials, intermediaries, and products.
To ensure data integrity, softwares with audit trailing and administrative permission features has been installed for liquid and gas chromatography systems (Agilent).
To ensure data security, Dell servers and uninterruptible power supplies (UPS) are used.
QA
The company also has an independent QA department, and the quality system is established in accordance with ICH guideline document Q7 and Chinese GMP regulations (2010 version).
In order to ensure the quality of our products, we are also continuously updating our quality system.
CERTIFICATES
As a professional API manufacturer, the company has EU-GMP certificate, Drug Manufacturer License, CEP certificates and Written Confirmation.