【ICH 之窗27】如何保持物料包装在运输中的完整性？？

2017年11月10日 18:32 医药注册研发资讯

5. Q. A packaging/labeling question;transport of API outside the facility, can boxes containing API be sealed with tamper-evident tape, or must the inner bottle or container be sealed?

问：包装/标签的问题：把原料药运到室外，装有原料药的盒子必须用胶带封闭吗？或者必须用内装瓶或是容器封口？

The guidance is basically asking that you put a seal so that you can tell whether or not someone opened it and did anything to the material under normal conditions. The answer, in my opinion, is that's fine. If you use unique tape and can tell if it had been opened, you've certainly satisfied the intent of the guidance.

答：指南基本上只是要求你必须有封口，这样你就可以判断是否有人打开过它和对它做过什么。答案是，在我看来，这就可以了。如果你使用特殊的胶带，并可以判断是否被打开过，那么你就满足了指南的要求。

Any measure you can take to ensure the integrity of that material while it's in transport is most beneficial to you and to your clients. There are many ways of doing that, not only of using seals that have specific designs, which may be hard but may not be impossible to imitate. Some companies use some kind of markings that, under normal lightingare not visible, and are only visible under UV lighting or special lighting conditions to mark containers. The persons receiving this material know that if they look for those markings in specific locations with special lighting, ifit's missing, that's usually an indicator that that's not their original material.

为了确保你的物料在运输中的完整性，你可以采取的措施必须最大可能的有利于你和你的客户。有很多方法来做这件事，不单单是使用指定设计的封条，这可能很困难但是并非不可以模仿造假。一些公司使用一些印记，在可见光下不可见，只有在紫外光下或是指定的光线条件下可见，来标记容器。物料接收者知道如果他们在指定的位置使用特殊的光线来检查，如果标记不存在，那么这就是一个信号，表明这已经不是他们原来的物料了。

Don't forget that the Agency is very concerned about the potential for counterfeit APIs. So, obviously, if you make it difficult for somebody to hide a change in the material, you make it much more difficult to put something else into your box or your container.

不要忘记药政当局非常关心原料药造假的问题。所以，很明显，如果你让别人很难隐藏物料的改变，你将使往你的盒子或是容器中添加其他东西变得更加困难。

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