ESG Report 2022

As a professional pharmaceutical manufacturer the composition test, sample test, label and packaging G r o u p u n d e r s t a n d s t h e i mp o r t a n c e o f i n s p e c t i o n , t r a n s p o r t a t i o n a n d s t o r a g e pharmaceutical quality and its impacts on public management as well as strict control and testing health. The Group has always considered quality over every process from raw and auxiliary assurance to be one of the top priorities in its materials, unfinished products to finished products. business. In order to achieve the highest level of Through our vertically integrated production and quality assurance, the Group strictly complies with operation model, every production process and t h e r e l e v a n t l a w s a n d r e g u l a t i o n s o n quality control procedure, starting from the entry of pharmaceutical management. We have established raw materials to the export of finished products, is a comprehensive quality management system traceable so as to ensure all the products meet while abiding by the law, which helps realise relevant standards. effective quality control procedures through 6.1 Quality Management 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 Provisions on the Administration of Pharmaceutical Directions and Labels Pharmaceutical Description and Labelling Administrative Regulations of Quality of Pharmacovigilance Practice Pharmacovigilance 6.1.1 Quality Management System Each of the Group’s production sites has confirm that the supplier is a qualified supplier, and established a comprehensive quality management shall check the completeness of the packages, system, which is managed comprehensively by the batch number, specifications, storage condition Quality Authorised Person. Under the lead of the and production date of the batch of raw and Qu a l i t y Au t h o r i s e d Pe r s o n , t h e Qu a l i t y auxiliary materials item by item. To ensure the Management Department coordinates the work of health and safety of raw materials, we would sign q u a l i t y a s s u r a n c e , q u a l i t y i n s p e c t i o n , quality assurance agreements with suppliers and pharmacovigilance, drug registration, etc. require them to provide relevant safety evaluation reports. Storage of materials is also an important The Group’s quality management system was step in the production process. To ensure proper implemented in accordance with the national storage of materials, the Group has also formulated Quality Management System Requirements. The relevant regulations on warehouse storage, management system includes a series of temperature and humidity control, etc., so as to comprehensive procedures, such as the arrange a suitable storage environment according warehousing, storage and distribution procedures to the features of materials. As for transportation, of raw and auxiliary materials and finished we have signed quality assurance agreements with products, so as to implement strict quality control of the commissioned logistic company to guarantee all types of raw and auxiliary materials and finished the quality and compliance of products upon products. During the acceptance of raw and delivery to market. auxiliary materials, the acceptance personnel must Relevant Laws Regulations and Realm 28 Environmental, Social and Governance Report 2022 The United Laboratories International Holdings Limited