Validation question
Posted: Fri Jan 11, 2013 3:13 pm
When performing accuracy in an HPLC method validation each extraction is performed with 10 capsules and other methods I have seen use 10 of this or that as per protocol. Is it written somewhere (ICH, FDA) that 10 samples must be used for each extraction? can 3 or 5 be used? please point me in the direction where I can find this information in the ICH or FDA guidelines, thank you.