ESG Report 2025
Pharmaceuticals are special products directly related to public health, product responsibility encompasses multiple dimensions including quality assurance, safety supervision, information disclosure and customer service. The United Laboratories strictly complies with laws and regulations relating to pharmaceutical administration and has established an end-to-end responsibility management system covering R&D, production and after-sales stages to ensure that every step meets the highest standards. In terms of quality management, we have built a quality governance framework directly supervised by the Board and senior management, achieving full-process traceability and control from incoming raw materials to outgoing finished products. 8.3 Product Responsibility 8.3.1 Quality Management System The United Laboratories has always regarded product quality as the lifeline of its corporate development and has established a quality management framework under the direct oversight of the Board of Directors and senior management. The Group's corporate officer, as the primary responsible person for drug quality, is fully accountable for providing the necessary resource support and ensuring that the quality management department performs its duties independently. Under the coordination of the quality officer, the Quality Assurance Department, the Quality Control Centre, the Pharmacovigilance Department and the Drug Registration Department work together to form a top-down quality management system, cascading quality objectives down to each production base, workshop and position, ensuring that every employee has a clear responsibility for product quality. The Group's quality management system is established and implemented in strict compliance with the national “Quality Management System Requirements” (GB/T 19001-2016 / ISO 9001:2015), covering the entire product lifecycle from R&D, technology transfer and commercial production to product discontinuation. In terms of system architecture, we have established a four-level documentation system consisting of a management manual, guiding documents, standard operating procedures (SOPs) and records/certificates, ensuring that every aspect of quality management is guided by documented procedures and supported by verifiable evidence. From the receipt and storage of raw and auxiliary materials to the release of finished products, we implement strict quality control: upon receipt, we confirm that the supplier is an approved supplier, and check item by item the packaging integrity, batch number, specification, storage conditions and date of manufacture; we sign quality agreements with suppliers and require them to provide safety assessment reports; we establish detailed temperature and humidity control specifications for warehousing to ensure proper storage of materials; and we sign quality agreements with logistics companies to ensure that product quality is not compromised during transportation. 64 Quality Authorised Person Quality Control Centre Qualified Person Quality Assurance Department Note: 1. CAPA (Corrective and Preventive Actions) management refers to the measures taken to eliminate the occurrence of detected non-conformities or other undesired conditions, as well as the measures taken to eliminate the occurrence of potential non-conformities or other potential undesired conditions. Regulatory Affairs Department On site management Training management Complaint, return and recall Verification management 1 Deviaton and CAPA management Change management Internal inspection Material and supplier management Document and archive management Risk management Comprehensive management of pharmaceutical administration Environmental monitoring Stability assessment Sample retention Reporting Inspection Sampling Drug registration Delegate Authority Person The United Laboratories International Holdings Limited 2025 Environmental, Social and Governance Report
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