FDA对注射剂相关控制点与工程实践.pdf

北京药学会2007年会-制药工程组 FDA对注射剂相关控制点与工程实践 FDA对注射剂相关控制点与工程实践 肖俊 肖俊 2007.12.22,北京 2007.12.22,北京 北京药学会2007年年会 1 北京药学会2007年年会 1 无菌药品 无菌药品 FDA - Sterile product: FDA - Sterile product: One or more elements exposed to aseptic One or more elements exposed to aseptic conditions and ultimately making up the sterile conditions and ultimately making up the sterile finished drug product. finished drug product. 无菌产品 = 药物 + 容器 + 封闭元素 通过: •无菌工艺(Aseptic process – AP) •终端灭菌(Terminal sterilization – TS) NB:今天内容主要偏向于无菌注射产品生产的工程实践 北京药学会2007年年会 2 北京药学会2007年年会 2 FDA的无菌生产指南 FDA的无菌生产指南 • Sterile drug manufacturers should have a keen • Sterile drug manufacturers should have a keen awareness of the public health implication of distributing awareness of the public health implication of distributing a nonsterile product. Poor cGMP conditions at a a nonsterile product. Poor cGMP conditions at a manufacturing facility can ultimately pose a life- manufacturing facility can ultimately pose a life- theatening health risk to a patient theatening health risk to a patient • Nearly all drugs recalled due to nonsterility or lack of • Nearly all drugs recalled due to nonsterility or lack of sterility assurance in period spanning 1980-2000 were sterility assurance in period sp