From November 20th to 24th, the World Health Organization (WHO) prequalification inspection team conducted the third on-site review of the live attenuated Japanese encephalitis vaccine project of Chengdu Institute of Biological Products. Yang Jingpeng of the State Drug Administration and Yang Zinan and Lin Tao of the Sichuan Provincial Drug Administration participated in the inspection as observers.
During the inspection, WHO inspectors conducted a comprehensive and systematic inspection of the quality management system of Chengdu Company, production quality management, quality control, aseptic process control and computerized system management of live attenuated Japanese encephalitis vaccine, and gave constructive suggestions. Dr. Tang Yi, a project appointed by the World Health Organization (WHO) Representative Office in China, participated in the inspection to provide corresponding support.
At 4 p.m. on November 24, the inspection officially ended. At the last meeting, the inspectors spoke highly of the operation and maintenance of the live attenuated Japanese encephalitis vaccine production line of Chengdu Institute of Biological Products, affirmed the achievements of the company's quality management system construction, and put forward valuable opinions and suggestions for further improvement and rectification. At the meeting, Yang Huichuan, President of China Biotech, thanked the WHO inspectors for their valuable guidance, and emphasized that rectification needs to draw inferences from one another, strengthen the quality integration construction within the enterprise and the group, and strengthen the construction of the group's quality culture, quality concept and quality awarenessYang Jingpeng, observer of the State Drug Administration, expressed his expectation on behalf of the State Drug Administration to continuously strengthen communication and exchanges with the WHO, and made it clear that the State Administration will continue to pay attention to the rectification of the enterprise and urge the company to carry out benchmarking and rectification work with other products.
Juling ** Chain has cooperated with Chengdu Biology for a long time, using a set of WMS to manage various business forms of Chengdu Biological raw materials, intermediates, finished products, spare parts, and external warehouses, and realize functions such as warehousing, QA, QC, release from the Central Institute for Inspection and Quarantine, multiple sets of traceability code traceability, segmented research and development, and sub-packaging. With the help of Juling's rich experience in industrial medicine, Chengdu Biotech has established a set of GMP audit requirements that meet the GMP audit requirements of the Food and Drug Administrations of the United States, China, the European Union, Arabia and other countries, and realizes CSV verification services with the help of GAMP national standards.
The article part**self from *** Chengdu Biological.
Focusing on the consulting management, implementation services and product development of digital chain software (WMS warehouse management system, WCS warehouse control system, LES logistics execution system, TMS transportation management system, BMS billing management system) and automation hardware integration services, Juling Chain has rich experience in chain management and operation. In the past 20 years, we have accumulated many years of industry best practices and applied them to leading companies in many industries and fields.
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