20140827 ECA新闻：关于“目视检查”的问答

20140827 ECA新闻：关于“目视检查”的问答  

2014-09-01 11:52:50|  分类： ECA新闻 |  标签： |举报 |字号大中小 [url=]订阅[/url]

原文网址http://www.gmp-compliance.org/enews_04426_Questions-and-Answers-on-the-Topic-%22Visual-Inspection%22.html

GMP News
27/08/2014

Questions and Answers on the Topic "Visual Inspection"

关于“目视检查”的问答

On the topic of visual inspection of parenterals there are always questions on how to implement in practice. The following Q&As are supposed to support you in this implementation.

关于静脉注射液的目视检查问题，总是有一些关于在实践中如何实施的问题。以下问题可以在实施中帮助到你。

Question 1: How often have employees of the manual (or semi-automatic) inspection have to be trained? What does "regularly" mean in this context?

问1：进行人工（或半自动）检查的员工要多久培训一次？在这里“定时”是指多少时间？

With regard to visual inspection, the difference between initial qualification and requalification must basically be made. Strictly speaking, requalification is an examination of the stand of a person's qualification. It is recommended to re-qualify employees every 3 to 6 months.

谈到目视检查，上岗培训和再培训要从根本上区分开来。严格地说，再培训是对一个员工的操作资格的一种检查，建议生3-6个月进行一次。

Question 2: The grey portion of fully automatic control is often checked manually, to return not clearly or fully tested products back to the inspection process. Is it allowed to carry out this testing with the automated inspection machine?

问2：全自动控制的灰色部分通常是人工检查的，它将不澄清的或全部已检测的产品返回到检查过程中去。是否允许采用自动检查设备来进行该项检查？

From a GMP view, there are no restrictions. It is also important here that at the end a yield calculation and evaluation in the batch record appears. And there are also automated inspection systems that have already integrated the double inspection with multiple cameras.

从GMP角度来说，是没有限制的。这里很重要的一点是在批记录中最终的收率计算和评估。也有一些自动检查系统已经被整合成多相机双重检查设备。

Question 3: Is AQL testing mandatory as a part of the visual inspection?

问3：AQL测试是否是目视检查必不可少的一部分？

A direct requirement cannot be derived from the EU GMP. Yet, the AQL tests correspond to the state of the art in science and technology. Since we know that neither man nor machine can prevent particles in the containers for being overlooked up to 100%, an additional measure - like the AQL tests - is certainly appropriate. Another method would be of course a second 100% control. Or you could show in the validation that the test method 100% succeeds, what will hardly be possible in practice.

EU GMP中并没有这样的直接要求，但是，AQL测试对应的是理想的科学技术。由于我们都知道人工和机器均无法100%地保证检出容器中颗粒物，因此采用额外的措施（例如AQL测试）肯定是适当的。另一个方法是采用第2个100%控制，或者你可以在验证中证明检测方法会100%的成功，但这在实践中几乎是不可能的。

Question 4: Are there legal acceptance criteria or provisions regarding the size of (visible) particles?  

问4：关于颗粒的大小（目视）是否有法规可接受标准或条款规定呢？

According to studies by Jules Knapp, people can recognise particles under optimal conditions from 30 - 50 ?m, taking into account the colour of the particle. Other studies have shown that eventually particles from approximately 200 ?m can be surely detected - in other sources, values of 50-80 ?m can be found. There are (still) no statutory limits on the size of the visible particles.

根据JULES KNAPP的研究，人们肉眼在较好视线条件下，同时考虑微粒颜色情况下，可以发现30-50?m的微粒。其它研究表明约200?m的微粒肯定是可以被检查到的，在其它来源中，50-80?m的微粒是可以被发现的。暂无可见微粒大小的法定限度。

Question 5: Can one 'reject' test be considered as a good after two "good" inspection on the same machine?

问5：一份被“拒收”的样品在同一台机器上经过2次“结果良好”的检查后是否可以认为是一个好的样品？

This is possible in a few cases where - for example - the machine stopped and goods were therefore ejected. Otherwise, "reject" should always remain "reject". This is particularly applicable to "bad" goods which have been rejected because of particles or opacity. Containers sorted out due to cosmetic defects are however usually being re-inspected.

这时可能出现不同情况-----例如----设备停止，产品因此被拒。否则，“被拒”只能维持作为“被拒”状态，这种情况特别适用于“坏”产品因为微粒或透明度的问题被拒时。由于容器外观缺陷而被拒的样品一般是可以进行再次检查的。

Question 6: Are there empirical values about how long do lamps in semi-automatic testing stations keep their intensity?

问6：半自动检查站的灯可以在多长时间内保持其强度是否有经验值？

Here, the certificates of the lamp manufacturers should be consulted. As a rule, 2-3 years are indicated.  Frequently, the lamps will be exchanged routinely after one year to never have to question the test results due to possible lamp weakness retroactively.

这里，可以参考灯的生产商的证书。一般来说会指明是2-3年。更多时候，每1年常规地把灯换掉，这样就永远不会因为灯的照度不够而被质疑

（译者：这个方法倒是简单，不过可不是增加成本么？只能是利益风险分析吧）

该资料来自一个新浪博客的朋友的，楼主是原始状态转的