压片时必须要金属探测器吗？

20150930 ECA新闻：压片时必须要金属探测器吗？  

Are Metal Detectors mandatory in Tableting?
压片时必须要金属探测器吗？
The European Medicines Agency (EMA) maintains a site with answers to frequently asked questions regarding GMP. This site has been updated this year and now also provides an answer to the question with regard to the mandatory use of metal detectors in tableting.
EMA有一个网址是回复关于GMP的常见问题。该网址本年度有更新，现在也提供关于在压片中是否必须要使用金属探测器的问题回复。
Metal particles may come from raw materials or, as in the case of tableting, from the equipment - for example, due to damage of the moving metal parts in a press. In cases where this is possible, the Agency recommends the use of metal detectors. If there is no routine use of metal detectors, the company needs to demonstrate that their use is not necessary. This might be difficult in practice.
金属颗粒可能来自于原料，在压片过程中来自于设备，例如由于压片机金属部件移动产生的磨损。如果是这种情况，当局建议使用金属探测器。如果常规地不使用金属探测器，公司就需要证明他们不需要使用。这样的证明在实践中可能是很困难的。
Find this and more interesting GMP answers on the EMA's Q&A site.
在EMA问答处可以找到关于此问题的答案以及更多有意思的GMP答案。


来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720159997056/