ESG Report 2024
The Group’s quality management system was developed and implemented in accordance with the “National Quality Management System Requirements” (GB/T19001-2016 / ISO 9001:2015). The management system includes a series of comprehensive procedures, such as the warehousing, storage and distribution procedures of raw and auxiliary materials and finished products, so as to implement strict quality control of all types of raw and auxiliary materials and finished products. During the receipts of raw and auxiliary materials, the acceptance personnel must confirm that the supplier is a qualified supplier, and shall check the completeness of the packages, batch number, specifications, storage condition and production date of the batch of raw and auxiliary materials item by item. To ensure the health and safety of raw materials, we would enter into quality assurance agreements with suppliers and require them to provide relevant safety evaluation reports. Storage of materials is also an important step in the production process. The Group has also formulated relevant regulations on warehouse storage, temperature and humidity control, etc., so as to arrange a suitable storage environment according to the features of materials. As for transportation, we have entered into quality assurance agreements with the commissioned logistic company to guarantee the quality and compliance of products upon delivery to market, ensuring the quality of our products from being compromised. The Group has established an effective quality risk management procedure, applicable to various activities of pharmaceutical product quality management within the company and to various quality risks that exist or may potentially arise throughout the life cycle of the products. This procedure is designed to guide the identification, analysis, evaluation, control, review, and communication of risk factors in the quality management process of pharmaceuticals, covering the entire life cycle from research and development, technology transfer, commercial production, to product discontinuation. Its purpose is to effectively implement risk management, reduce risk damages, and ensure the safety and efficacy of pharmaceutical products. In addition, we have set up procedures for the release of products. The procedures stipulated that only raw materials, semi-finished and finished products that have passed quality tests could be passed to the next procedure to avoid the use of any raw materials, semi-finished and finished products that are non-conforming to standards and specifications for production or sale. For non-conforming raw materials and finished products, we will identify, investigate, return or collectively destroy them based on the relevant management procedures for non-conforming products, effectively eliminating any potential quality hazards. In order to further improve quality management, the Group conducts irregular risk assessments of the quality of various products each year to identify potential risk points and develop corresponding control measures. The main purpose of testing is to identify potential risks to product quality and safety, covering aspects such as testing frequency, background, subjects, results, and handling methods to ensure comprehensive and effective risk management. Besides, the Group performs an annual review of product quality, thoroughly assessing all quality indicators, deviations during the production process, and changes in production equipment. This process includes proposing improvement measures to continuously optimise the quality management system, ensuring the stability and reliability of product quality. 35 Risk Treatment Initiate Risk Management Process Record and Report Risk Assessment Risk Identification Risk Analysis A quantitative or qualitative risk (subnode) Risk Assessment Whether the risk is acceptable? What might go wrong? Communication and Consultation Environmental, Social and Governance Report 2024 The United Laboratories International Holdings Limited Select the most appropriate risk response plan and implement it Monitor and Review
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