About Sterility And BET Method Validation


I need to know the features of method validation about sterility and BET.

I know how to perform the analysis but im confused about the analytic parameters.

1- May i have to perform the product positive control for 3 times for each batch ( probably yes ) and another analyst have to perform it 3 times more?

I’ve got a paragraph in my SOP about it, but im confused. It says the first analyst will perform the analysis for 2 times. And the second analyst will perform it one more. It becomes 3 in total.
Is it true ? Can you please explain ?


You have to validate the analytical method for total 3 times with 3 batches. Some companies use to validate with different analysts but it doesn’t matter for others. If it is written in your sop to get it done by two analysts then follow it. Again you have to prove that your product is not interfering with the analysis in both test methods.
Remember that you have to validate analytical methods for all products those you analyze using these methods.