Congratulations to the company on successfully passing the dynamic acceptance inspection of veterinary biological diagnostic products.

Jan 16,2020


From October 11 to 12, a GMP expert team consisting of three members—Jiang Yuwen, Director of the New Drug Review Center at the China Veterinary Drug Supervision Institute; Li Junping, Director of the Bacteriology Laboratory; and Tan Kelong, an expert from the Virology Laboratory—conducted a dynamic acceptance inspection of the company’s veterinary biological diagnostic product production line, accompanied by Zhang Zhimin, Director of the Provincial Department of Agriculture and Rural Affairs, and Jin Shiqing, Director of the Provincial Drug Administration. Yang Zhongxing, General Manager of the company, and Zhao Kehong, Manager of the Quality Management Department, along with other relevant personnel, accompanied the inspection team. This is the second acceptance inspection following the successful completion of the static acceptance inspection on April 8.

 

  From October 11 to 12, a GMP expert team consisting of three members—Jiang Yuwen, Director of the New Drug Review Center at the China Veterinary Drug Supervision Institute; Li Junping, Director of the Bacterial Testing Laboratory; and Tan Kelong, an expert from the Viral Testing Laboratory—conducted a dynamic acceptance inspection of the company’s veterinary biological diagnostic product production line, accompanied by Zhang Zhimin, Chief of the Provincial Department of Agriculture and Rural Affairs, and Jin Shiqing, Director of the Provincial Drug Administration. Yang Zhongxing, General Manager of the company, and Zhao Kehong, Manager of the Quality Management Department, along with other relevant personnel, also accompanied the inspection. This is the second acceptance inspection following the successful completion of the static acceptance inspection on April 8.

  The experts conducted acceptance inspections of the veterinary biological diagnostic products workshop, warehouse, quality management department, and other facilities. They also carried out on-site assessments of production line personnel and inspectors from the quality management department. Subsequently, they administered theoretical knowledge and competency tests to the relevant staff. Finally, the experts unanimously concluded that the company’s production workshop area and space are appropriately matched to its production scale; its production processes are reasonable; its production and inspection facilities adequately meet production requirements; all relevant documentation is complete; and the personnel have passed their assessments. Therefore, they recommend that the company’s veterinary biological diagnostic products production line be certified as GMP-compliant.

  

 

 

  At the final meeting, the experts offered reasonable comments and suggestions regarding the company’s management and documentation shortcomings. The acceptance process has now been successfully completed!

 

 

  The company successfully passed this acceptance inspection, opening up new horizons in the development of biological products. Building on this fresh starting point, we will continue to forge ahead and provide strong support for the development of biological products in Hebei Province.


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