1. The company has established and improved the quality management system, and established a management organization suitable for drug production, mainly including quality assurance department, quality control department, storage and transportation department, pharmacovigilance department, production department, engineering equipment department, supply department and human resources department; The qualifications of key personnel and management personnel at all levels meet the requirements, and the responsibilities of institutions and personnel at all levels are stipulated.

2. The company has established a complete document system, and established the company's technical standards, management procedures, operating procedures and other documents.

3. The company's plant facilities, equipment, instruments, etc. have been verified.

4. The company has carried out GMP related knowledge training for personnel at all levels.

5. The company strengthens quality risk management, formulates a series of risk management documents, and makes detailed provisions on risk classification, personnel responsibilities, basic procedures for risk management, risk analysis tools, etc., and focuses on the identification and control of possible quality risk points such as major equipment/systems/processes.

6. In order to ensure the standardized implementation of GMP, the company has set up a GMP self-inspection team to conduct a comprehensive self-inspection of the company's GMP implementation on a regular basis, rectify the problems found in the inspection in a timely manner, and formulate preventive measures to continuously improve the production quality management system of drugs.

The total area of the quality control laboratory is 1600m2. The functional room and instrument facilities are complete, and the physical and chemical testing, instrument testing, biological testing, microbial limit verification and standard solution and titration preparation are carried out in separate rooms. Equipped with international well-known brands of liquid phase, gas phase, infrared, ultraviolet, particle size and other advanced testing instruments, can meet the inspection requirements of products.