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The company has established a comprehensive quality management system, formulated a series of SOPs, and strictly implemented them. All operations are recorded and traceable; We have established a timely and effective procedure for customer quality complaints and product recalls. Verification management, change management, deviation management, risk management, etc. are integrated throughout the entire product lifecycle. For many years, our company's product quality has been stable, and the market sampling pass rate is 100%, enjoying a good market reputation. In addition to strictly managing the production of products in accordance with relevant SOPs, the company is also equipped with advanced testing equipment such as high-performance liquid chromatography, gas chromatography, and liquid mass spectrometry to control the drug production process and test the release of finished products; Our company also has a dedicated quality research team to conduct Develop and validate testing methods, and conduct quality research work including impurity separation, identification, and tracking. The commonly used analytical instruments currently used by the company are as follows: Instrument name and model High performance liquid chromatograph Agilent 1200; HP 1100; Waters; Shimadzu et al High efficiency gas chromatograph HP6890; Agilent4890; Shimadzu Particle analyzer Malvern MS2000 Total organic carbon analyzer Shimadzu TOC-Vwp Infrared spectrophotometer Bruker Tensor 27 Differential scanning calorimeter Mettler DSC823e Ion chromatograph Dionex ICS-90A Liquid mass spectrometry Agilent 6120 Inductively Coupled Plasma Emission Spectrometer Shimadzu ICP-9000 |