Auleon Biologicals
News
13
2023
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10
Warmly congratulate Chongqing Aolong biological cell suspension culture virus inactivated vaccine (including suspension culture process) production line successfully passed the GMP static acceptance
Author:
From September 23 to 24, 2023, at the invitation of the Chongqing Agricultural and Rural Committee, an inspection and acceptance team composed of veterinary drug GMP experts Wu Tao and Mao Yaqing of the Ministry of Agriculture and Rural Affairs, in accordance with the "Veterinary Drug Management Regulations" and "Veterinary Drug Production Quality Management Practices (Revised in 2020)", "Veterinary Drug Production Quality Management Practice Inspection and Acceptance Measures" and "Veterinary Drug GMP Inspection and Acceptance Evaluation Standards" and other laws and regulations, the production line of cell suspension culture virus inactivated vaccine (including suspension culture process) of our company was subjected to GMP static acceptance. Investigator from the Animal Husbandry and Veterinary Department of Chongqing Agricultural Commission organized the acceptance on behalf of the Municipal Agricultural Commission. GMP experts and Zhang Wei, chief of Rongchang Animal Husbandry Development Center, participated in the whole process of inspection and acceptance. Du Chengcai, director of the Animal Husbandry and Veterinary Department of Chongqing Agricultural Commission, accompanied the inspection and acceptance.
The expert group strictly enforced the work process, strictly controlled the evaluation standards, and strictly observed the work discipline. After listening to the work report of the production director Liu Xin on the operation and implementation of the production line GMP at the first meeting, they conducted a comprehensive, detailed and in-depth implementation of the production line GMP. On-site inspection, the production line, product type, production process, quality inspection, raw and auxiliary material warehouse, etc. were checked one by one, and the problems existing in the on-site inspection were assessed on the operators and inspectors. The expert group also carefully consulted GMP documents and various related archives, and conducted a forum for key personnel to assess national regulations, post operating procedures, technical standards, instrument and equipment management, and enterprise quality management documents.
After two days of careful inspection and assessment, this acceptance involves 282 inspection items, including 54 key clauses and 228 general clauses. The inspection and acceptance team agreed that Chongqing Aolong Biological Company has a sound organizational structure, clear functions, and personnel structure, professional quality and training conditions meet the requirements; the environment of the factory and workshop meets the specified standards; the layout of the factory and production plant is reasonable, and its area and space are suitable for the production process; the environment, facilities and testing instruments of the quality inspection room meet the requirements; the main equipment, process, production water, etc. were confirmed and verified, the production equipment can meet the production requirements, the production management and material management meet the requirements, and the quality control and quality assurance documents meet the requirements. Comprehensive evaluation of the on-site inspection and comprehensive assessment results qualified, relevant post personnel theoretical knowledge and personnel quality, and production conditions meet the requirements.
After serious discussions, the inspection and acceptance team fully affirmed and encouraged the implementation of GMP for biological and veterinary drugs in our company, and also pointed out our shortcomings. Finally, the inspection and acceptance team successfully passed the inspection and acceptance with 96.5 points, recommend the production line of cell suspension culture virus inactivated vaccine (including suspension culture process) of Chongqing Aolong Biological Products Co., Ltd. as a GMP qualified production line for veterinary drugs.
At the final meeting of inspection and acceptance, Xie Jianyong, chairman of Huapai Group, expressed his deep admiration and gratitude to all experts and leaders for their serious and responsible, disciplined, and tireless work style! He stressed that inspection and acceptance is not only a legal procedure, but also the inspection and assessment of veterinary drug GMP after static acceptance of Aolong biological cell suspension culture virus inactivated vaccine production line, which can effectively standardize our future work standards and quality, strengthen the management of weak links, improve GMP management level and enhance the market competitiveness of enterprises through continuous rectification and improvement.
On behalf of all the staff, General Manager Fu Gang expressed his heartfelt thanks to the expert group for its guidance and help. He said that we will strictly implement the relevant national laws and regulations, immediately set up a veterinary drug GMP rectification team, carefully sort out all the defective items proposed in the inspection and acceptance, formulate rectification measures, quickly implement rectification one by one, and timely submit the qualified rectification items to the expert group for review. At the same time, we will take the unqualified items found in the static acceptance of veterinary drug GMP as the starting point, adhere to the normalization and comprehensiveness of GMP management, strengthen the fine and standardized management of GMP work, adhere to the enterprise concept of "diligence leads to ownership, innovation can last for a long time", have the courage to explore and innovate, dare to take responsibility, go all out to achieve new breakthroughs and shape the quality of a century, for China's animal disease prevention and control, public health safety and animal-derived food safety to make more protection!
Ran Zhiguang, deputy general manager of Chongqing Aolong Biological Products Co., Ltd., Wang Meigui, deputy general manager, Liu Xin, production director, Tang Zhicheng, financial director, and management personnel of each center participated in and witnessed the on-site acceptance activity.
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