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The company takes Q7A and other ICH documents as the quality management guide, and has an independent quality assurance department and quality control department according to GMP requirements. There are quality laboratory, chemical analysis room, instrument analysis room and microbiology examination room.
All kinds of management standards, technical standards, operating procedures, strictly implement change management, deviation management, verification, verification, self-inspection, quality review, quality management system, from material procurement, production process, to product release, user information feedback, such as the operation process of monitoring and management, process design, process confirmation and continuous process confirmation of three stages of comprehensive process verification, to ensure the quality of stability and excellence.
The main product of sarbolisha sodium (8- (2-hydroxybenzamide) sodium) has successfully obtained China CDE and FDA double registration number (CDE: F20220000072; USDMF: 037135).