Relative to Section 8.2 on time limits, does stability of a batch under certain processing conditions need to be established by laboratory studies or historical processing data in order not to have to specify time limits? Do max hold times need to be established based on historical data or laboratory stability studies?
Typically you would use is your historical data. For a new process you could establish a tentative
hold time. As your database grows and you have additional data on a product at those conditions,
you could extend the hold time.
