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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1.6.1
brunnerbalazs
- Sep 11, 2023
- 2 min
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, 2023
- 1 min
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, 2023
- 2 min
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, 2023
- 2 min
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, 2023
- 4 min
(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, 2023
- 2 min
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, 2023
- 2 min
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, 2023
- 1 min
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, 2023
- 1 min
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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