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Independent and Integrated QA System

Hualan Biological Engineering Inc. and its subsidiary company, Hualan Biological Bacterin Co., Ltd. establish independent and integrated QA system, which guarantees effective implementation of specification formulating of critical factors in potentiality of affecting quality and product release; guarantee its quality implementation independent from the interference of the company itself and other departments. Based on quality risk assessment, the QA systematically analyzes and monitoring the trend of the risk factors that will affect the quality and drug stability. Hualan quality department make sure its personnel knowledge and experiences in GMP compliance status by trainings the manufacturing and quality related staffs; independently supervise the whole process of manufacturing and QC to avoid errors, contamination and confusion; implement quality control on all materials in manufacturing, establishing supplier archives and periodically conducting on-site auditing for critical material manufacturers; installing integrate GMP document system to ensure the consistency and traceability of data and information generated in the whole process from the purchasing of raw and subsidiary materials, manufacturing to drug release and distribution; and by mean of periodic self-inspection (internal auditing) and product quality review to timely monitor potential defects existing in the quality management and trends in quality to control the drug manufacturing always in the validated state.

 

Hualan biological continuously improving its QA system and the QP (qualified person) system was implemented since Oct, 2009 to strengthen its quality safety management and the consciousness. Meanwhile, Hualan biologicals proactively sought GMP consulting to strengthen its quality management, adopting advanced management concept from EU and other foreign sides, and made qualification & validation of new workshop complying with EU criteria on the premise of Chinese GMP qualification. Participate in all kinds of trainings organized by regulatory authorities, such as WHO vaccine risk management, absorbing beneficial international management experiences to enhance and develop company’s soft power and continuously improving quality management system to guarantee reliable product with excel quality and efficiency and safeguard a good reputation on its brand promotion and the user experience through its advanced quality management so as to support the company’s strategy therefore to leading the quality management of Chinese biopharmaceuticals industry. Hualan Biological is dedicated to develop its products not only for the domestic people, but also for the people who need most especially in the developing countries at high quality and affordable price.