Q7A would not expect revalidation if you haven’t changed anything. Your change control system
should still be operating. If you’ve made no changes to what you’re going to do, and it’s the same
facility with the same equipment, Q7A does not mandate another series of extra work. Now, if
you’re a conservative manufacturer, you may want to do some additional work, additional testing
to assure that the process will still produce API in a consistent manner. But, by no means does
this guidance require that additional work if nothing has changed.
