今天刚刚看到的、发生在米国FDA的警告信New Warning Letter calls for Risk Assess...

胜利者

In a recent Warning Letter issued to a pharmaceutical company based in North Carolina, the U.S. Food and Drug Administration FDA explicitly asks the company to perform risk assessments.
The company produced both human drugs and several pesticides in the same building and with the same equipment. This is certainly a 'no go' for the FDA. The company now has to provide a risk assessment for all drugs which have been produced on the equipment also used for pesticide production and evaluate the "risk of potential contamination due to the shared equipment", and to address "the product quality and patient safety risks for any product still in distribution within expiry, including potential recalls or market withdrawals".
Even worse, the company had no adequate cleaning validation in place. Also here the FDA now wants a "risk evaluation that addresses the potential for each of your human drugs to be cross-contaminated with any other products".
Please also see the FDA Warning Letter to Ei LLC for more detailed information.

beiwei5du

这个有一个案例，是以前的ChemRite CoPac的警告信，其中涉及到OTC生产线不仅生产药品，还生产toxic  car care product。
有一个说明的是，FDA并不禁止其他任何产品和药品生产共线（除青霉素外）。
其基于的是你自身如何的控制，正如现在的EMA shared faclity那个guidance一样，也都是基于你的评估和控制。
如果你能控制住，那么这种生产方式并没有问题的。
我正看到一篇文章进到这个,mark一下：

This leads to some inevitable questions, such as: whether FDA would allege a violation of the FDCA if only the first two conditions had occurred but not the third, or if only the first condition had occurred. In other words, does the FDA believe that the FDCA forbids the manufacture of non-pharmaceuticals on pharmaceutical equipment regardless of whether or not the non-pharmaceuticals manufactured are toxic to humans? If so, what is the regulatory basis for this claim?

One also has to wonder how FDA would respond if ChemRite provided the agency with data that showed in a validated way not only that their dual use manufacturing equipment could be thoroughly cleaned without leaving a residue, but that in fact the equipment had been thoroughly cleaned prior to each of the lots of drug product manufactured on this equipment, without leaving any residue from the non-pharmaceutical manufacturing.

选自：

Word to the Wise (Drug Manufacturer): Don’t Use Your Manufacturing Equipment to Produce Toxic, Non-Pharmaceutical Products

蓝色星期六

这个情形在国内都很少见

曾江波

看起来比较麻烦。

beiwei5du

难道不应该吗？

贝多芬的画笔

为什么不划分区域啊，或者搞两个厂啊？

xueyide3721

蓝色星期六 发表于 2018-6-6 22:38
这个情形在国内都很少见

会有，但是没有发现，嘿嘿

昌黎

这种情形在警告信里确实不多见啊！

并肩

罕见，评分最高

yixihongye

这个厉害了。。。

山顶洞人

没说啥剂型，挺好奇的，这玩意可以给崇洋媚外的重大打击啊！

老K

beiwei5du 发表于 2018-6-7 07:26
难道不应该吗？

米国本土的厂吧

无敌的寂寞

这个太夸张了，国内好歹还做做样子，这家厂子干脆连样子都不做了，耿直

kokosiki

学习下  这个可以借鉴下人家的经验和技术

灵光

这个貌似太严重了吧  这么不严谨的生产线不会制造出毒药吧？

tzhqx3

不是看得很懂

ahy199386

围观学习围观学习