美国兽用体外杀虫剂的原料药是否需要进入洁净区生产
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美国兽用体外杀虫剂的原料药是否需要进入洁净区生产?和口服固体制剂的原料药生产是否要求一致?

ICH Q7没有找到对于兽药体外杀虫剂的洁净区要求,是否有相关的美国法规描述可以参考?

2017-07-27 10:09 Rachel     
1个回答

如果你说的化合物是药品(drug)的话,21 CFR 210211是适用动物原料药的。

21 CFR 210  Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.

 

21 CFR 211 contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.  

 

如果不确定是否是 drug的话,查看FDA 网站 Animal & Veterinary

 

2017-08-02 12:38 Hang