From June 10 to 11, 2022, Changzhou Tongtai Biopharmaceutical Technology Co., Ltd. successfully passed the inspection and acceptance of the new version of GMP after comprehensive and careful inspection and assessment by the GMP acceptance expert group of the Ministry of agriculture and rural areas.
According to the new version of the Ministry of agriculture and rural areas "veterinary drug production quality management specification (revised in 2020)" and "veterinary drug production quality management specification inspection and acceptance evaluation standard (revised in 2020)" and other laws and regulations, the GMP acceptance expert group of the Ministry of agriculture and rural areas and the leaders of provincial and urban competent departments inspected and accepted the reconstruction and expansion project of our veterinary drug GMP workshop. The acceptance expert group listened to the report on the GMP operation of our veterinary drugs in the form of remote video conference, and according to the acceptance plan, the expert group conducted on-site special inspection and post operation assessment on our quality inspection center, laboratory animal room, production workshop and other places through remote online video, on-site inspection and other forms; Carefully reviewed various management documents, bacterial and virus species and cell management, product batch records, staff training and other aspects; Ask questions, assess and exchange experience with key personnel in the form of discussion.
According to the requirements of the new version of veterinary drug GMP, the expert group evaluated and comprehensively judged the implementation of the new version of veterinary drug GMP by our company one by one, and believed that our company had a good implementation of the new version of veterinary drug GMP, a sound enterprise organization, clear functions, personnel structure and training meet the requirements, the environment and hygiene of the plant and workshop meet the specified standards, the laboratory environment and equipment, testing instruments meet the requirements, and the production equipment meet the production requirements, At the same time, it puts forward guidance and rectification opinions for incomplete details. After the comprehensive evaluation of the expert group, we are unanimously recommended as a qualified enterprise of veterinary biological products with the new version of GMP.
The successful acceptance not only confirms the effectiveness of our new version of GMP, but also provides a new impetus for the company to continue to improve product quality and strive for industry benchmarks in the future. We will continue to summarize the experience of carrying out the new version of GMP, further improve the comprehensive quality of employees, strengthen production quality management and biosafety work, and build a domestic first-class animal biological products enterprise.