ESG Report 2024

7.1 Quality Management As a professional pharmaceutical manufacturer, the Group understands the importance of pharmaceutical quality and its impacts on public health. The Group has always considered quality assurance to be one of the top priorities in its business. To achieve the highest level of quality assurance, we strictly complies with the relevant laws and regulations on pharmaceutical management and have established a comprehensive and rigorous internal quality management system. From raw and auxiliary materials, and intermediates to finished products, we conduct strict quality control at every stage, including ingredient testing, sample testing, label and packaging verification, as well as transportation and storage management, ensuring the effective implementation of quality control procedures. Through our vertically integrated production and operation model, we achieve full traceability from the entry of raw materials to the export of finished products, ensuring that every production stage and quality control procedure meets relevant standards, thus providing consumers with safe and reliable products. 7.1.1 Quality Management System Each of the Group’s production sites has established a comprehensive quality management system, which is overseen comprehensively by the Quality Authorised Person. Under the guidance of the Quality Authorised Person, the Quality Management Department coordinates and oversees quality assurance, quality inspection, pharmacovigilance, drug registration, ensuring that all processes are strictly executed and providing comprehensive assurance for product quality. 34 Quality Authorised Person Quality Control Centre Qualified Person 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 Pharmaceutical Administration Law of the People's Republic of China Regulations for the Implementation of the Drug Administration Law of the People's Republic of China Good Laboratory Practice for Non-Clinical Laboratory Studies Standards for Quality Control of Pharmaceutical Production Measures for the Supervision and Administration of Drug Production International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines Guidelines of Quality System Approach to Pharmaceutical cGMP Regulations by FDA Guidelines of Good Manufacturing Practices for Drug by the European Union ISO 9001: 2015 Quality Management Systems Certification Pharmaceutical Quality Quality Risk Management Regulations Document Management Regulations Deviation Handling Program Investigation Procedure for Out of Specification (OOS) Inspection Results Corrective and Preventive Action Management Procedure Verification Management Regulations Product Review and Release Management Procedure Change Control Management Regulations 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. Environmental, Social and Governance Report 2024 The United Laboratories International Holdings Limited Aspects Regulations and Guidelines Internal Policies Regulatory Affairs Department Environmental monitoring Stability assessment Sample retention Reporting Inspection Sampling Drug registration Delegate Authority Person