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 ?