自制一级对照品需不需要做结构确证，美国这边有没有法规规定？

birdo

如题，请大家帮帮忙，个人觉得是需要的，而且业内也是这么做的，但是苦于找不到法规依据（报美国项目），说服不了公司某些同事。想请教大家一下：美国申报法规对于自制一级对照品需不需要做结构确证，有没有规定呢？另外，杂质的一级对照品是不是可以免做结构确证呢（个人觉得也是要做的）？能否请大家提供一下法规的规定（仅限于美国这边的，欧盟的规定已经找到），非常感谢！

北重楼

当然需要呀

hlx

做了安全  谁来检查都不怕

razhanghui

ICH Q7中有提到需要对非官方的一级对照品做fully identify，虽说是针对API的，但杂质应该也适用吧
Primary reference standards should be obtained, as appropriate, for the manufacture of APIs. The source of each primary reference standard should be documented. Records should be maintained of each primary reference standard’s storage and use in accordance with the supplier’s recommendations. Primary reference standards obtained from an officially recognized source are normally used without testing if stored under conditions consistent with the supplier’s recommendations. (11.17)
Where a primary reference standard is not available from an officially recognized source, an in-house primary standard should be established. Appropriate testing should be performed to establish fully the identity and purity of the primary reference standard. Appropriate documentation of this testing should be maintained. (11.18)

jiangbj

razhanghui 发表于 2016-11-25 16:28
ICH Q7中有提到需要对非官方的一级对照品做fully identify，虽说是针对API的，但杂质应该也适用吧
Primary ...

有理有据

birdo

razhanghui 发表于 2016-11-25 16:28
ICH Q7中有提到需要对非官方的一级对照品做fully identify，虽说是针对API的，但杂质应该也适用吧
Primary ...

非常感谢您的解答！