Company organized the relevant production activities strictly in accordance with the Good Manufacturing Practice (GMP). There are QA (Quality Assurance) and QC (Quality Control) departments under the company quality management system, they exercise the quality assurance and quality control functions respectively.
QA department is responsible for establishing the management system of drug production complying with the current GMP requirements of China, United States, Europe, Japan and other countries, and implementing effective supervision to ensure the system operation. The department sets up full-time QA personnel to be responsible for evaluating the material suppliers, raw materials purchase, in-coming materials testing, production process, finished product release, distribution, customer feedback and whole process supervision to standardize and improve the quality management system. In addition, the company actively organizes training of regulatory update and continuously improves the quality management system through periodical self-inspection and customer or official audit.
QC department is mainly responsible for testing of raw materials, finished products, intermediates and process water used in the production and monitoring of environmental conditions. To ensure the smooth progress of product quality control work, the company established a professional testing team with nearly 200 members, and equipped with international advanced testing equipment, such as LC-MS (Liquid Chromatography-Mass Spectrometry), GC-MS (Gas Chromatography-Mass Spectrometry), HPLC (High Performance Liquid Chromatography), GC (Headspace Gas Chromatography), Malvern Particle Size Detector, X-ray powder diffractometer, Automatic Polarimeter, IR (Infrared Spectrometer), Dissolution instrument, etc.. We implement the scientific data integrity management requirement and completely create a high level and high efficiency detection condition.
LC-MS (Liquid Chromatography-Mass Spectrometry): LCMS 6460
GC-MS (Gas Chromatography-Mass Spectrometry): GCMS-TQ8040
HPLC (High Performance Liquid Chromatography):1260
GC (Gas Chromatography):7890B+7697A
Particle Size Detector: Malvern MASTERSIZER 2000
Malvern MASTERSIZER 3000
X-ray Diffractometer, type: GNR APD2000
atomic absorption spectrometer： AAnalyst 400
IR, Type: Thermo 380 FI-IR
Milli-Q ultra-pure water meter