关键词: font-size:medium, ">生物制品；分段生产；六大系统；生产质量管理

Abstract:  In order to support the high-quality development of the biomedical industry， the NMPA has initiated a pilot program for segmented production of biological products. As this pilot program gradually unfolds， the traditional single-site production model of biological products has shifted to segmented production at different sites. This may introduce some new potential risks， such as the unification and cohesion of the quality management systems of the holder of the drug marketing authorization and the segmented production enterprises， the consistency of production processes and quality control under the segmented production model， and the performance and technical risks related to the transfer and handover of intermediate products. This article analyzes and discusses the key points of quality management for segmented production of biological products by sorting out relevant regulatory guidelines on commissioned production and segmented production of biological products， combining the characteristics of biological products， and focusing on the differences and risk points under the segmented production model， starting from the six major systems of drug production quality management. It aims to provide ideas and references for Chinese biological product manufacturers to adapt to the new model of industrial development and further improve quality management， while also providing reference for drug inspection.

Key words: font-size:medium, ">Biological products； Segmented production； Six major systems； Production quality control