益生菌制剂车间GMP设计探讨

Discussion of GMP Design of the Probiotics Workshop

通过分析益生菌及其制剂特性,在满足生产要求,立足于国家相关法律法规的基础上,对设计原则、生产工艺、车间GMP设计等方面进行了探讨,提出了紧凑合理布局车间的方法,以达到便于生产操作和管理、协调人物流、防止交叉污染、提高生产区域效能、保障产品安全的目的。

By analyzing the probiotics and the characteristics of their preparations, based on the relevant laws and regulations, the design principles, the productive processes, and GMP design of the workshop were discussed. The close and rational layout of the workshop was proposed, which satisfy the purposes of making the production operation and management convenient, coordinating the flowing route of the staff and the material, preventing cross-contamination, improving the efficiency of the productive area and ensuring the security of the product.