EUGDMP数据：济南金达药化欧盟GMP检查失败

EUGDMP数据：济南金达药化欧盟GMP检查失败

2015-07-29 11:28:19

|  分类：

EU GMP

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.

感谢分享！！！！！！！