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1.6.1
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...
brunnerbalazs
Dec 5, 20232 min read
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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...
brunnerbalazs
Sep 11, 20232 min read
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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...
brunnerbalazs
Jul 29, 20231 min read
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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...
brunnerbalazs
Jul 28, 20232 min read
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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....
brunnerbalazs
Jul 28, 20232 min read
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(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...
brunnerbalazs
Jul 25, 20234 min read
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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...
brunnerbalazs
Jul 25, 20232 min read
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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...
brunnerbalazs
Jul 13, 20232 min read
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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...
brunnerbalazs
Jun 26, 20231 min read
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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...
brunnerbalazs
Jun 14, 20231 min read
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