I have some discussion on analyst qualifications
What type materials can be used and what types batches can be used
For example ihave a stability samples(exhibit batch) , samples Stability period completed and sample expired the sample to be use or not .
Type your Question clearly
Stability samples are used for analyst qualifications after completion of stability period is it acceptable or not.
analyst qualification assures that analyst being preformed the analysis as per STP without any deviations. Here no need select stability samples in stability section. Other passed batches can be selected. or just completed stability samples can be selected.
My question is expired samples are used for analyst qualification it is acceptable or not
No, reasently approved batch u take and perform
But I think still the question is not answered. Pls tell whether the expired stability samples can be useful for conducting analyst validation, as these samples are also from passed or approved batches
This is my actual question.
For this expect answer.
NO expired stability samples can not be used
Otherwise it lead always question for the analysis he did for the stability batches if any problem occured in the stability batches >>> worst case it will be difficult to handle OOS / OOT kind of things if analysis performed by the analyst got not trained in the lab environment…and not familior with the product behaviour…
I got a question hoping you help me please.
Is there another estadistic method for analyst qualifications??, if there can you send an example please. And where i can learn more about it .
Expire sample can not be used
First of all please Refer your Analyst qualification SOP what you mentioned.
You never use Expired sample and also stability sample, You only use Running coming last Approved Batches , Because The Result of new analysts should be compared with Approved Batches(As per SOP criteria mentioned).
If you used Expired sample Unexpected Result may be observed.