FDA关于兽药青霉素生产线的疑问

beiwei5du

各位蒲友：

在FDA cGMP中211.42（d)有提到：
(d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use.
同时在211.46（d）中提到
(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.


想咨询一下美国对于兽药的青霉素类生产线是否共线有单独的规定？？

顾永强

谢谢分享，下载学习。

cnosema

呃，兽用青霉素也归FDA管哈。然后，，，就不用问了吧

cnosema

而且，你贴的211.46，要求的是通风系统，估计共线就不用想了？

北重楼

估计不太合适吧

beiwei5du

cnosema 发表于 2016-6-23 07:33
呃，兽用青霉素也归FDA管哈。然后，，，就不用问了吧

我想问的是为什么没有and for animal use.

cnosema

beiwei5du 发表于 2016-6-23 09:20
我想问的是为什么没有and for animal use.

也许，用的是同一个标准，所以不用区分 for human use or for vet use呢？

cnosema

beiwei5du 发表于 2016-6-23 09:20
我想问的是为什么没有and for animal use.

还想到一个，就是也许FDA不关注动物的青霉素过敏（如果有这个的话）？所以只是强调，任何青霉素产品的生产过程，不能污染其它的人用药品的生产过程，（至于是否会污染其它动物用药品的生产，在这里没有提及）。

beiwei5du

cnosema 发表于 2016-6-23 10:55
还想到一个，就是也许FDA不关注动物的青霉素过敏（如果有这个的话）？所以只是强调，任何青霉素产品的生 ...

这个还真找到了。选自CGMP 1978 preamble

      140. A number of comments objected to applying the requirements of 121.42(d), 211.46(e), and 211.176 to the manufacturer of penicillin and nonpenicillin veterinary products. They claim that no evidence has been offered to demonstrate penicillin sensitivity in animals.  It was proposed that the word "human" be inserted before the words "drug products."     Hypersensitivity reactions to penicillin do occur in animals. Although the Commissioner acknowledges that at present there is less information on the extent of the problem in animals than in humans, he advises that FDA has received numerous reports of reactions in animals throughout the years. Therefore, the Commissioner believes the requirement as proposed in 211.176 is warranted and has retained it in the final regulation.  However, the Commissioner believes that the prohibition against the use of common facilities and air-handling systems in the production of veterinary drug products is not necessary at this time.  Therefore, 211.42(d) and 211.46(e) (now 211.46(d)) are revised accordingly in the final regulation.