FDA对注射剂相关控制点及工程实践--肖俊.pptVIP

北京药学会2007年年会 北京药学会2007年年会-制药工程组 FDA对注射剂相关控制点与工程实践 肖俊 2007.12.22,北京 无菌药品 FDA - Sterile product: One or more elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. FDA的无菌生产指南 Sterile drug manufacturers should have a keen awareness of the public health implication of distributing a nonsterile product. Poor cGMP conditions at a manufacturing facility can ultimately pose a life-theatening health risk to a patient 无菌产品的质量要求 无菌 内毒素 微粒 化学交叉污染 灌装量 配液的浓度 冻干质量(如果是冻干产品) 污染源与处理方法 关键点 (ISO13408-1) Steps which include handling by personnel of sterile product, im