ESG Report 2019

13 QUALITY MANAGEMENT A s a p r o f e s s i o n a l p h a r m a c e u t i c a l procedures through composition test, sample manufacturer, the Group understands the test, label and packaging inspection, importance of pharmaceutical quality and its transportation and storage management as impacts on public health. The Group has well as strict control and testing over every always considered quality assurance to be process from raw and auxiliary materials, one of the top priorities in its business. In unfinished products to finished products. order to achieve the highest level of quality Through our vertically integrated production assurance, the Group strictly complies with and operation model, every production the relevant laws and regulations on process and quality control procedure, starting pharmaceutical management. We have from the entry of raw materials to the export of established a comprehensive quality finished products, is traceable so as to ensure management system while abiding by the law, all the products meet relevant standards. which helps realize effective quality control QUALITY MANAGEMENT SYSTEM Each of the Group's production sites has established a comprehensive quality management system, which is led by a quality officer. Under the lead of the quality officer, the Quality Management Department coordinates the work of quality assurance, quality inspection, pharmacovigilance, GMP information regulations, drug registration, etc. Category Relevant Laws, Regulations and Guidelines Pharmaceutical Quality Quality Authorised Person Quality Assurance Department Registration Department Quality Inspection Department Pharmacovigilance Department GMP Regulations Department GMP Information Department Quality Management Department Pharmaceutical Description and Labelling Provisions on the Administration of Pharmaceutical Directions and Labels The 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 Good Manufacturing Practice for Pharmaceutical Products Measures for the Supervision over and Administration of Pharmaceutical Production ICH Guidelines Guidelines of Quality System Approach to Pharmaceutical cGMP Regulations by the FDA Guidelines of Good Manufacturing Practices for Drug by the European Union Environmental, Social and Governance Report 2019 The United Laboratories International Holdings Limited

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