Hello everyone! Why the OCC QC sample is not required for stability testing during bioanalitical method validation!? In both FDA and EMA guidences stability at LQC and HQC levels is sufficient. But from the "logical point of view" to assure that your samples above the curve are stable is to prove OCC QC stability as well.
Hello Tigran,
In ISO15189 stability testing is advocated for samples, reagents etc. In the Netherlands we have made a guiding document regarding method validation and verification.
https://www.eflm.eu/upload/docs/Verification%20and%20Validation%20-%20Dutch%20NS.pdf
About method validation and verification I held a lecture last month at a international meeting in Slovenia, some items of this lecture may be usefull as well.
Conference Paper Verification and validation of examination procedures accord...
regards
Jos
Dear Jos,
Thank you for the answer and for the interesting papers!
But still I didn't get the answer to my question. During the bioanalytical method validation we should have calibration curve and quality control samples in different levels (LLOQ QC, LQC, MQC, HQC and OCC QC)for different purposes.
To assure that our analyte is stable during the whole path of sample analysis different stability test (long therm, bench-top, freez-thaw, in autosampler, etc) should be done. Samples which calculated concentration are above the calibration curve should be diluted and re-analysed (OCC sample). And here is the question-if you are not testing OCC QC during stability testing, what is the main argument that your samples which are out of calibration curve are stable?
Regards,
Tigran
OCC-Out of calibration curve.
In case of QC it's the same "dilution QC"
Dear Tigran,
I think it is an omission of the American demands not to mention OCC stability.
ISO15189 made it simple by stating: you need to validate / verificate all that is necessary. That leaves a question like yours to the professional judgement. Strictly speaking you are not obliged to test OCC stability, but it is wise (and according to professional judgement) to do so.
Dear Jos,
Yes, as you said it would be wise to test OCC also, but from the other point of view if it's not required why to spend money and time. Also I investigated different CRO's reports which were submeted to FDA and ~9 from 10 companies were not including OCC. I started to think maybe during some conferences or forums this question was discussed and based on some data it was decided that LQC and HQC levels are sufficient!?
It remains a matter of time / financial means on one side and professional judgement on the other side.
Guidelines are in my opinion meant to support the professional and not to be seen as laws, written in stone ..
Yes, I understand your point!
But on the same time, from the scientific side, if we accept bracketing approach and if we are speaking about stability can it happen that we have a degradation at higher levels but not at lower?! I think no! If we are speaking about solubility issues at the highest level, than probably dilution integrity should cover it!?
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