FDA 483_齐鲁天和制药 2015年5月和6月检查

kslam

消息来自RAPS,RegulatoryAffairs Professionals Society 2016年2月10日

Qilu Tianhe Pharmaceutical’s manufacturing site in Jinan, China -- wasinspected by FDA twice back in May and June, with 15 observations cited.

齐鲁天和制药(山东省济南市) 在2015年5月和6月之间被FDA检查两次, 列举15个483缺陷。

During an inspection of the company’s quality control lab, FDA found partiallyincomplete or “otherwise undesirable” gas chromatography results were movedinto an auxiliary folder entitled “test.” The large number of sample setswithin this test folder “containing TNTC [too numerous to count] unreportedsample injection results for finished APIs prevented our comprehensive reviewof the results,” FDA said. These types of sample "tests" were alsouncovered at Indian manufacturing sites last year.

质量控制实验室的检查,FDA发现部分不完整或“或"不理想的”气相色谱结果移入题为"检验"辅助文件夹。FDA说这个测试文件夹中的大量样本集“包含TNTC[不计其数未报告的API成品的进样结果以阻止我们全面进行审查结果。

FDA also found that the Qilu site failed to follow batch manufacturinginstructions and lab control procedures, in addition to questions about thefacility’s design.

除了设施的设计问题, FDA还发现齐鲁工厂没有按照批生产指令和实验室控制程序

补充内容 (2016-5-21 16:05):
FDA发出483表给三个设施:

齐鲁天和惠世制药有限公司   5/26 - 6/2/2015
齐鲁制药有限公司           5/11 - 5/19/2015
齐鲁安替制药有限公司       9/14 - 9/22/2015

幻影

是不是该重新排排版。。

kslam

FDA检查员 : Peter E. Baker and Chiang Syin  

孙艳红

Peter E. Baker ,实验室杀手

Enjoy

又见杀手啊…………

zysx01234

感觉莫名起码，没有很具体啊

hplc2010

怎么不全啊！

beiwei5du

贴图显示，检查员非常细致谨慎啊。这个应该是针对于注射剂制剂的检查吧。