金币
UID173742
帖子
主题
积分178
注册时间2014-4-28
最后登录1970-1-1
听众
性别保密
|
欢迎您注册蒲公英
您需要 登录 才可以下载或查看,没有帐号?立即注册
x
[size=14.6667px]ICH Q7A4.34条 Where the manufacturer of a nonsterile API either intends or claims that it is suitable for use in further processing to produce a
sterile drug (medicinal) product, water used in the final isolation and purification steps should be monitored and controlled for total microbial counts, objectionable organisms, and endotoxins.
当非无菌原料药的制造商打算或者声称该原料药适用于进一步加工生产无菌药品(医疗用品)时,最终分离和精制阶段的用水应当进行微生物总数、致病菌和内毒素方
面的监测和控制
请问下这里描述的[size=14.6667px]内毒素指标是否和注射用水内毒素指标是一致(小于0.25EU/ml )
|
|