Ayman Rabayah
☆    

Jordan,
2023-06-15 09:14
(402 d 04:09 ago)

Posting: # 23595
Views: 1,644
 

 Including duplicates of Low, medium and High QCs during analytical method validation [Regulatives / Guidelines]

Dear colleagues

can you advise and share your practices about the following text in the latest M10 guideline for the bioanalytical method validation?

"For non-accuracy and precision validation runs, low, medium and high QCs may be analysed in duplicate. These QCs, along with the calibration standards, will provide the basis for the acceptance or rejection of the run."

are the stability runs which contains low and high QC levels are considered non-accuracy run?
what are the non-accuracy runs during the method validation and how can the duplicates of the low, med and high QCs be assessed to decide the run accepted or rejected if the run itself not designed for the accuracy (recovery as example or carry over).

if we have an analytical method validated without including these replicates, should the method be re-validated?

please advise and share your thoughts, thanks in advance.
dshah
★★  

India/United Kingdom,
2023-06-15 10:36
(402 d 02:48 ago)

@ Ayman Rabayah
Posting: # 23597
Views: 1,330
 

 Including duplicates of Low, medium and High QCs during analytical method validation

Hello Ayman!

ICH provides this information in QC sample preparation.

❝ "For non-accuracy and precision validation runs, low, medium and high QCs may be analysed in duplicate. These QCs, along with the calibration standards, will provide the basis for the acceptance or rejection of the run."


❝ are the stability runs which contains low and high QC levels are considered non-accuracy run?

❝ what are the non-accuracy runs during the method validation and how can the duplicates of the low, med and high QCs be assessed to decide the run accepted or rejected if the run itself not designed for the accuracy (recovery as example or carry over).

The acceptance criteria is: For non-accuracy and precision validation runs, at least 2/3 of the total QCs and at least 50% at each concentration level should be within ±20% of the nominal values.

It is not necessary to have replicate QC levels but they help in acceptance/rejection of run.

Regards,
Divyen
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