GA黄金甲

Quality and Safety Management Policy

Sino Biopharmaceutical has set up a full-life circle quality management system under the direct leadership of the heads of member companies. The quality management work runs through the whole process of drug research and development, manufacturing, assistance, sales and use, arouses the enthusiasm of all staff, extensively carries out quality management group activities, and carries out quality improvement in an organized, planned and continuous way through PDCA (Plan-Do-Check-Action) cycle, to continuously meet the requirements of market customers and regulations.

1. Management system: For feeding, production, warehousing, inspection and verification, the Group formulates Deviation Management, Business Continuity Management, Corrective and Preventive Measures Management and other management systems; For the distribution and use of drug, management systems such as Adverse Medicine Reaction Monitoring Report Management and Pharmacovigilance Management have been formulated to enhance the ability to respond to drug safety emergencies.

2. Business continuity risk control: Analyze and assess risks affecting business continuity, eliminate or reduce risks from different levels through various measures, and regularly check or drill relevant measures to ensure the effectiveness of the emergency system.

3. Deviation investigation and correction: For any deviation from approved product standards, regulations, conditions, safety, environment, etc., the Group shall initiate deviation investigation procedure to find out the cause of the problem and take further corrective and preventive measures according to the cause. After completion, the effectiveness of the corrective and preventive measures shall be evaluated.

4. Medication safety management mechanism: A Pharmacovigilance Department is set up to monitor and report adverse drug reactions to prevent medication safety risks.

5. Product recall: The Group classifies the recall work according to the degree of drug quality hazards. The recall time limit is within 24 hours for class I, 48 hours for class II, and 72 hours for class III. If the drug is found to have potential safety risks in the process of adverse reaction monitoring, the Group will carry out drug recall, investigate the cause, take corrective and preventive measures, and make a return visit and check the recall effect. Recall implementation and treatment of recalled drugs shall be timely submitted to the Drug Regulatory Department for approval, and a recall summary report shall be formed and submitted to the drug regulatory department.

6. Quality culture construction: continue to build the quality and safety culture of the Group, and carry out quality and safety training covering all staff at least once a year.

Supplier Quality Management Policy

In order to strengthen supplier management, optimize supplier resources and improve work efficiency, Sino Biopharmaceutical has formulated the Supplier Quality Management Process, which regulates the working procedures of supplier development, supplier daily management, supplier performance management and supplier quality audit.

1.Supplier development: Select suppliers based on the principle of paying equal attention to quality, cost, delivery and service, and do sufficient preliminary research before the development of suppliers.

2.Daily management of suppliers: The Group has established a supplier database with unified management and continuous optimization, formulated a complaint handling process, and the Procurement Department and relevant quality department should update the qualification of suppliers regularly. Each Procurement Department shall carry out regular training covering all suppliers at least once a year, the training shall cover the topics of quality management, environmental management, safety management and other topics, and conduct regular or irregular visits to suppliers.

3.Supplier performance management: The Procurement Department and the user department shall evaluate the supplier's services, and formulate hierarchical incentive schemes according to the performance assessment results of suppliers.

4.Supplier classification: Suppliers are divided into four categories according to the impact degree of the materials they provide on the quality of products.

5.Supplier quality audit: On-site audit shall be conducted every 3 years for Category 1 suppliers (except packaging material suppliers), on-site audit shall be conducted every 5 years for Category 1 suppliers and domestic and foreign packaging material suppliers, and letter audit shall be conducted every 5 years for Category 2, 3 and 4 suppliers. In case of major quality problems or changes of suppliers, unqualified incoming inspection for two consecutive times, or potential quality problems found in the process of use, conduct additional audit to ensure that the material quality meets the Group's product requirements.

6.The Group encourages suppliers to obtain quality management system certification. For major sub-suppliers of the Group, the Procurement Department or a third party shall carry out supplier certification.