All production lines of Jinxi Phase I have passed GMP certification


Release time:

2016-03-17


A few days ago, the Bosch production line of cephalosporin powder injection in Jinxi Pharmaceutical Factory of Jianfeng Pharmaceutical Co., Ltd. obtained GMP certificate through the publicity of the State Food and Drug Administration. So far, all production lines with production capacity in the first phase of Jinxi Pharmaceutical Factory have all passed the new GMP certification.
In this certification, the inspection team sent by the Food and Drug Audit and Inspection Center of the State Administration, in accordance with the provisions of the "Drug production quality Management Standard (revised in 2010)", Appendix 1 and sampling appendix, based on the principle of risk management, combined with the key quality attributes of the products in the production workshop of Bosch production line of cephalosporin powder injection of the pharmaceutical company, with production process and sterility assurance as the main line, a check list, and trace the necessary situation. The key inspection contents are sterility assurance for drug production, process prescription and registration approval (provincial bureau process prescription verification) sterilization process, process consistency, risk management application, confirmation and verification of key equipment and facilities, daily monitoring of public works system, deviation and change control, quality management system, data integrity, etc. According to the on-site inspection schedule, the inspection team conducted on-site inspection of the pharmaceutical company's powder injection (cephalosporins, second-line) production plant, storage, central laboratory, process water, air purification, compressed air, nitrogen system, etc., and communicated with relevant personnel to check the relevant management system, documents and original records, dynamic inspection of bottle washing, rubber plug cleaning, sub-packaging, rolling cap, lamp inspection, packaging and other processes.
After on-site inspection and risk assessment, the inspection team believes that the overall risk of the Bosch production line for cephalosporin powder injection is controllable, and the production quality management meets the new GMP management requirements without serious defects. After the rectification is completed and publicized by the National Bureau, the GMP certificate is officially issued.