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1.6.1
brunnerbalazs
Dec 5, 20232 min read
Chromatographic columns and their qualifications
We have mentioned earlier the importance of choosing and testing of the column when developing a chromatographic method. But what should...
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brunnerbalazs
Sep 11, 20232 min read
URS in AIQ - how to specify an analytical instrument?
We have covered several parts of the AIQ: a promotion for a couple of fine white papers, DQ, and PQ. Now let's start to think about how...
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brunnerbalazs
Jul 29, 20231 min read
Deviations during requalification
There was a post earlier about how to manage OOC investigations. But what if your service provider has its own deviation management...
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brunnerbalazs
Jul 28, 20232 min read
OOC/OOA - how to handle it?
In case of analytical instruments, some companies use the term Out-Of-Calibration, others use Out-Of-Acceptance for failed recalibration...
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brunnerbalazs
Jul 28, 20232 min read
Retest - when you need the most, but how?
Okay, here's a situation: you did your QC-test*, and the result is OOS out of the blue- but you know, you really know it is a lab error....
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brunnerbalazs
Jul 25, 20234 min read
(Not so) quick thought about GC method development
Let me think out loud about how to develop the perfect GC method for QC purposes. In pharma, there may be a lot of different GC-methods...
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brunnerbalazs
Jul 25, 20232 min read
AIQ - how about the IQ?
In former posts, we discussed the DQ in general, and the analytical instrument PQ. Now let's collect what we need to perform a thourough...
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brunnerbalazs
Jul 13, 20232 min read
AIQ - what should PQ contain?
Sometimes the question comes up: what should we really test during the PQ on a newly purchased analytical instrument? You did your best...
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brunnerbalazs
Jun 26, 20231 min read
OOS investigation step: Double-check with another lab
You may fall into an OOS investigation, when even after a thourough expedition, you have doubts if your lab does something wrong, or you...
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brunnerbalazs
Jun 14, 20231 min read
A couple of great white papers on USP 1058: AIQ
Agilent tries to help the companies understand the essence of the latest (2017) change in USP section <1058>: Analytical Instrument...
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