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lean manufacturing

Company quality system introduction

　　The company has established a quality management system based on scientific and risky product development process,declaration process and post-listing life cycle management.The person in charge of quality management department manages the quality team under the direct leadership of the person in charge of the enterprise.The quality management department of the first-level department is set up with registration and Compliance Department,quality research Department,QC Department and QA Department.Responsible for registration and compliance,quality research,quality inspection and quality management respectively.

　　The quality control center is equipped with complete and advanced testing instruments and an online data processing system that meets the requirements of data reliability.It has established inspection management procedures and product quality inspection procedures.It is equipped with an inspection team that has been trained and evaluated to meet the requirements.Ensure the accuracy and reliability of product quality inspection data.

　　The company establishes and improves the quality management manual and management procedures according to the requirements of cGMP and IS09001,and takes GMP as the guideline to standardize and improve various production and quality management procedures.It is equipped with a full-time QA team,organizes and carries out full staff training and retraining,and pays attention to the improvement of personnel quality.Manage and supervise the whole process from supplier evaluation,material warehousing acceptance,production process,quality inspection,product release,sales,customer service,etc.,organize daily on-site inspection,organize deviation treatment,change control,conduct annual quality review and trend analysis of product quality,and regularly organize GMP/ISO9001 self-inspection.Through corrective and preventive measures to achieve continuous improvement,all-round guarantee of product quality,our products have won a good reputation in the international and domestic markets.

　　The company has passed the IS09001 quality system certification,passed the Chinese GMP compliance inspection several times from 2022 to 2023,and plans to pass the FDA inspection in 2024.

1) GMP inspection history

Serial number	Inspection time	Product involved	Country/institution	Status
1	2016.09.12-2016.09.14	sofalcone	China/Hubei Food and Drug Administration	GMP certificate
2	2019.01.22-2019.01.24	Fasudil mesylate	China/Hubei Food and Drug Administration	GMP certificate
3	2022.07.07-2022.07.09	Voriconazole	China/Hubei Food and Drug Administration	GMP result notification
4	2023.01.04-2023.01.07	Voriconazole	China/Hubei Food and Drug Administration	GMP result notification
5	2023.07.11-2023.07.14	Posaconazole	China/Hubei Food and Drug Administration	GMP result notification