济南金达药化欧盟GMP检查失败

julia朱玉姣 · 发表于 2015-7-29 10:25:35

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本帖最后由 julia朱玉姣于 2015-7-29 12:03 编辑

检查时间：2015-6-26

地址:山东省济南市章丘市龙泉路6121号

检查官方：意大利

不符合情况：共18个缺陷，其中1个关键，6个重大。关键缺陷是不正式未受控存贮区域里有原料和成品，仓库门被移走后，换了一块板用螺丝固定在墙上，然后检查期间要求公司给弄开了。在此区域存贮的物料管理并不在质量保证体系内，检查员调查发现有严重的数据造假风险。

6个重大缺陷中的一个与类似问题有关，有一个被锁住的车库在检查官要求后才打开。

余下其它5个重大缺陷均与质量保证体系以下方面相关：培训、清洁验证、HPLC分析数据完整性破坏、微生物实验室、关键中间体合同生产商确认。
Nature of non-compliance : In total 18 deficiencies were identified by the inspection team, one of them was classified as critical and six as major. The critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall, which during the inspection the Company was requested to remove. The material stored in this area was to be managed outside of the Quality Assurance system and the investigation carried out by the inspection team concluded there was a serious risk of data falsification. One of the six major deficiencies was related to a very similar issue, as access to a locked garage was given to the inspection team only hours after requesting it. In both cases the explanations provided were not sound and different versions were given during the inspection. The remaining five major deficiencies were related to specific aspects of the Quality Assurance System with regards to training, cleaning validation, breaches of data integrity in the context of HPLC analysis, microbiological laboratory, qualification of contract manufacturer of a key intermediate of Nitrofurantoin production.

红茶. · 发表于 2015-7-29 10:30:48

车库？

yhdaizy@163.com · 发表于 2015-7-29 10:31:28

不正式未受控存贮区域里有原料和成品,有多少企业这样呢？！！！！

jackycheung · 发表于 2015-7-29 10:37:04

谢谢，朱丽叶。

Arlen · 发表于 2015-7-29 10:41:06

小黑屋，垃圾篓，都是风险高发地

Evan. · 发表于 2015-7-29 10:54:48

哎···似乎又一个倒在国门边境线上

syhorchid · 发表于 2015-7-29 10:56:53

哦？意大利的官方检查？

先亮 · 发表于 2015-7-29 10:57:29

济南金达药化的质量管理欠缺大了，要过欧盟认证，还弄虚作假，设小黑仓库？！

道路漫长黑暗 · 发表于 2015-7-29 11:01:28

这个层次的缺陷有点低，造假都不用心呢。

西文 · 发表于 2015-7-29 11:07:24

谢谢楼主提供的信息

miaoxiao · 发表于 2015-7-29 11:08:39

风险大呀，我们做制剂有联合申报的API，API生产厂基础差呀，难。

巴西木 · 发表于 2015-7-29 12:12:35

很多药厂都存在通病啊

xhf123456 · 发表于 2015-7-29 12:34:08

谢谢分享

北重楼 · 发表于 2015-7-29 12:42:32

这个是典型的偷吃腥，但嘴巴没擦干净，被抓了个现形，也给我们一个借鉴，还是得老实。

kuandailin · 发表于 2015-7-29 13:25:12

很有收获，非常感谢

kc1711422001 · 发表于 2015-7-30 15:22:40

Thanks for your share

wildpant · 发表于 2015-7-31 16:08:23

很多药厂都有非受控的仓储区。

Dragon三 · 发表于 2015-8-3 10:24:23

中国这么多企业都迎检这么多次国外检查了，居然还有小黑屋这样的事情发生，应该好好反省一下了。

pine · 发表于 2015-8-3 11:03:37

有不受控的仓库，物料平衡怎么做呢。

porsche1921 · 发表于 2015-8-3 11:14:43

谢谢分享

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