ESG Report 2023

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, the Group strictly complies with the relevant laws and regulations on pharmaceutical management. We have established a comprehensive quality management system while abiding by the law, which helps realise effective quality control procedures through composition test, sample test, label and packaging inspection, transportation and storage management as well as strict control and testing over every process from raw and auxiliary materials, unfinished products to finished products. Through our vertically integrated production and operation model, every production process and quality control procedure, starting from the entry of raw materials to the export of finished products, is traceable so as to ensure all the products meet relevant standards. 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 Relevant Laws and Regulations Pharmaceutical Quality Aspects 7.1.1 Quality Management System Each of the Group’s production sites has established a comprehensive quality management system, which is managed comprehensively by the Quality Authorised Person. Under the lead of the Quality Authorised Person, the Quality Management Department coordinates the work of quality assurance, quality inspection, pharmacovigilance, drug registration, etc. 36 Internal Policies 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 Environmental, Social and Governance Report 2023 The United Laboratories International Holdings Limited On site management Training management Complaint, return and recall Verification management 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 Quality Authorised Person Quality Assurance Department Quality Control Centre Regulatory Affairs Department Qualified Person