关于“无菌检查和热原检查除外”的疑问

beiwei5du

为什么在Q7A中针对于原料药，却没有无菌检测和内毒素检测除外的规定。
11.72  The reserve sample should be stored in the same packaging system in which the API is stored or in one that is equivalent to or more protective than the marketed packaging system.  Sufficient quantities should be retained to conduct at least two full compendial analyses or, when there is no pharmacopoeial monograph, two full specification analyses.  
而在USA的制剂CGMP中却有针对于API和制剂成品的留样量有除无菌检测和内毒素检测除外的规定

yc20160802

Q7A没有无菌检测和内毒素检测除外的规定，并不意味着绝对不测无菌检测和内毒素，是否检测参考药典相应规定。