Bioequivalence and Bioavailability Forum

Hello Loky do,

In addition to my response above, you should present updated SOP (in line with ICH M10) as a part of your CAPA.
To summersise, to the best of my knowledge follow below steps:

- Refer SOP/guideline effective at that time
- Try to have documented investigation
- Provide evidence of reproducibility of analytical method
- Prove that there is no impact on final BE outcome because of failure of ISR samples
- Update your SOP as per new guideline

I hope it will work.

Regards,
QA