关键词: font-size:medium, ">化学仿制药注射剂；注册生产现场检查；常见问题

Abstract: Objective：Based on the analysis on existing compliance problems and quality risks in pre-approval inspection of generic chemical injections,quality management recommendations were put forward to provide reference for the supervision of regulatory authorities and the construction and improvement of quality management system of pharmaceutical manufacturers. Methods：In this paper, the implementation of pre-approval inspections of 68 generic chemical injections registered in 2019 were collected, and the major problems were analyzed.Results：The GMP compliance problems in aseptic operation and personnel training, medium simulation filling test content, process validation and qualification, co-line production risk assessment and cleaning validation were relatively associated with higher incidence rates. Conclusion：For drug regulatory authorities, it is recommended to focus on the weakness of injection manufacturers for strengthened supervision. For injection manufacturers, it is recommended to strictly follow the requirements of relevant laws and regulations to further improve their sterility assurance capabilities. Besides,they have to comprehensively improve the quality of generic chemical injections and fully ensure the safety, effectiveness and quality control of drugs in China.

Key words: font-size:medium, ">Generic chemical injection, Pre-approval inspection, Common problem