检查官能给予Q7A发布检查报告吗？？

beiwei5du

检查官能给予Q7A发布检查报告吗？？这些概念搞不清楚，望指教。

ztzhang

所有的指南都没有法律约束力。所以，检察官必须得把缺陷性追溯到法律条款才行。每个检查报告的开头都会有描述，根据什么什么法律。。。。

zysx01234

Q7A只是参考，GMP规范采用法律效力。

工作QQ

https://www.ouryao.com/forum.php?mod=viewthread&tid=275985

2A2MXnrNlF

ztzhang 发表于 2016-5-31 12:22
所有的指南都没有法律约束力。所以，检察官必须得把缺陷性追溯到法律条款才行。每个检查报告的开头都会有描 ...

FDA发给API厂家的警告信並没有引用如21 CRF211条款于违规项目。FDA如何符合法规?

ztzhang

2A2MXnrNlF 发表于 2016-6-1 09:04
FDA发给API厂家的警告信並没有引用如21 CRF211条款于违规项目。FDA如何符合法规?

有的，引用的是联邦食品/药品/化妆品法案，一般来说是这个号：(FD&C Act),21 U.S.C.

2A2MXnrNlF

ztzhang 发表于 2016-6-1 10:04
有的，引用的是联邦食品/药品/化妆品法案，一般来说是这个号：(FD&C Act),21 U.S.C.

这联邦法典的那段话针对不符合CGMP为制药体系的要求、但不是各条款如21 CFR 211。

ztzhang

2A2MXnrNlF 发表于 2016-6-1 10:09
这联邦法典的那段话针对不符合CGMP为制药体系的要求、但不是各条款如21 CFR 211。

你是不是想人家FDA在每个观察项后面都注明法规出处啊。。。

工作QQ

There is no approved application under the provisions of Section 505 of the Act on file with the FDA for
Guaifenesin 1200 mg. sustained release tablets as marketed by your firm. Therefore, marketing of this
product without an approved new drug application constitutes a violation of Section 505(a) of the Act.
Our investigators also documented deviations from Current Good Manufacturing Practice (CGMP) for
Finished Pharmaceuticals Regulations (Title 21, Code of Federal Regulations, Parts 210 and 211) concerning
the manufacture of your drug products Coldec Tablets (Carbinoxamine Maleate, Pseudoephedrine HCl);
Crantex Tablets (Phenylephrine HCl and Guaifenesin), Dyphylline & Guaifenesin Tablets; Migrazone
(Isometheptene Mucate, Dichloralphenazone and Acetaminophen), Usept Tablets (Methenamine, Phenyl
Salicylate, Methylene Blue, Benzoic Acid, Atropine Sulfate and Hyoscyamine Sulfate) and Guaifenesin
Sustained Release Tablets. These deviations cause these drug products to be adulterated within the meaning
of Section 501(a)(2)(B).
http://www.doc88.com/p-491187580144.html
基于的是GMP，不是Q7a

2A2MXnrNlF

ztzhang 发表于 2016-6-1 10:24
你是不是想人家FDA在每个观察项后面都注明法规出处啊。。。

你还不知道制剂的警告信的各违规项有引用 21CFR211条款吗? 哈哈

cnosema

工作QQ 发表于 2016-6-1 10:27
There is no approved application under the provisions of Section 505 of the Act on file with the FDA ...

There is no approved application under the provisions of Section 505 of the Act on file with the FDA for
Guaifenesin 1200 mg. sustained release tablets as marketed by your firm. Therefore, marketing of this
product without an approved new drug application constitutes a violation of Section 505(a) of the Act.
Our investigators also documented deviations from Current Good Manufacturing Practice (CGMP) for
Finished Pharmaceuticals Regulations (Title 21, Code of Federal Regulations, Parts 210 and 211) concerning
the manufacture of your drug products Coldec Tablets (Carbinoxamine Maleate, Pseudoephedrine HCl);
Crantex Tablets (Phenylephrine HCl and Guaifenesin), Dyphylline & Guaifenesin Tablets; Migrazone
(Isometheptene Mucate, Dichloralphenazone and Acetaminophen), Usept Tablets (Methenamine, Phenyl
Salicylate, Methylene Blue, Benzoic Acid, Atropine Sulfate and Hyoscyamine Sulfate) and Guaifenesin
Sustained Release Tablets. These deviations cause these drug products to be adulterated within the meaning
of Section 501(a)(2)(B).
http://www.doc88.com/p-491187580144.html
基于的是GMP，不是Q7a

基于的是21CFR.210和211