ESG Report 2025

Product release is the last line of defence in quality control. The Group has established a stringent product review and release procedure, stipulating that only raw materials, semi-finished and finished products that have passed quality testing may proceed to the next production stage or be released for sale. The Qualified Person (QP) bears the final responsibility for release, ensuring that the production and testing of each batch of released product comply with relevant regulations, drug registration requirements and quality standards. Before release, the Qualified Person must review the batch production records, batch testing records, change control status, deviation investigation results, etc., and confirm that all required checks and tests have been completed and meet the requirements. For non-conforming raw materials and finished products, we strictly follow the non-conforming product management procedure for identification, investigation, return or centralised destruction, preventing any quality risk from entering the market. To continuously improve the quality management system, the Group conducts an annual product quality review, led by the Quality Assurance Department and with the participation of production workshops, the Quality Control Centre, equipment management and other relevant departments. The review covers all quality indicators, deviations during production, equipment changes, stability study results, complaints and returns, etc. Trend analysis of key quality attributes is performed using control charts, and process capability indices are calculated to evaluate process control levels. After the review report is approved by the quality officer, corrective and preventive actions are developed for identified issues, forming a complete closed loop from problem identification to action implementation and effectiveness evaluation. 65 In terms of risk management, the Group has established comprehensive quality risk management procedures, employing tools such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP) to identify, analyse, assess and control risks at each stage from R&D, technology transfer and commercial production to product discontinuation. Risk management activities cover key areas such as process design, production process control, change control, deviation management, validation, self-inspection, auditing and product quality review, ensuring that products released to the market are safe, stable and effective. The Quality Assurance Department regularly organises risk assessment meetings, inviting relevant departments such as production, engineering and technology to participate, conducting cross-departmental reviews of potential risk points, and developing and tracking the implementation of control measures. The Group's quality risk management process is illustrated in the figure below. Risk Treatment Initiate Risk Management Process Record and Report Risk Assessment Risk Identification Risk Analysis A quantitative or qualitative risk (subnode) Risk Assessment Whether the risk is acceptable? What might go wrong? Communication and Consultation Select the most appropriate risk response plan and implement it Monitor and Review The United Laboratories International Holdings Limited 2025 Environmental, Social and Governance Report