| ECA關于"目視檢查"的問答(二之一) |
Questionsand Answers on the Topic "Visual Inspection" With regard to visual inspection, the difference between initial qualificationand requalification must basically be made. Strictly speaking, requalificationis an examination of the stand of a person's qualification. It is recommendedto re-qualify employees every 3 to 6 months. From a GMP view,there are no restrictions. It is also important here that at the end a yieldcalculation and evaluation in the batch record appears. And there are alsoautomated inspection systems that have already integrated the double inspectionwith multiple cameras. Question 3: Is AQL testing mandatory as a part of the visual inspection? A direct requirement cannot be derived from the EU GMP. Yet, the AQL testscorrespond to the state of the art in science and technology. Since we knowthat neither man nor machine can prevent particles in the containers for beingoverlooked up to 100%, an additional measure - like the AQL tests - iscertainly appropriate. Another method would be of course a second 100% control.Or you could show in the validation that the test method 100% succeeds, whatwill hardly be possible in practice. Question 4: Are there legal acceptance criteria or provisions regarding thesize of (visible) particles? According to studies by Jules Knapp, people can recognise particles underoptimal conditions from 30 - 50 μm, taking into account the colour of theparticle. Other studies have shown that eventually particles from approximately200 μm can be surely detected - in other sources, values of 50-80 μm can befound. There are (still) no statutory limits on the size of the visibleparticles. Question 5: Can one 'reject' test be considered as a good after two"good" inspection on the same machine? This is possible in a few cases where - for example - the machine stopped andgoods were therefore ejected. Otherwise, "reject" should alwaysremain "reject". This is particularly applicable to "bad"goods which have been rejected because of particles or opacity. Containerssorted out due to cosmetic defects are however usually being re-inspected. Question 6: Are there empirical values about how long do lamps insemi-automatic testing stations keep their intensity? Here, the certificates of the lamp manufacturers should be consulted. As arule, 2-3 years are indicated. Frequently, the lamps will be exchangedroutinely after one year to never have to question the test results due topossible lamp weakness retroactively. |
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