What if a step has no specified time limit in the master production record, but you have an unexplained process delay? While waiting to make a solvent change, if you know that there’s no quality impact, then what sort of deviation or documentation would be expected?

Even though you do not have a time limit in your master instruction, if you do have an abnormal
delay, this is a deviation that should be evaluated. You want to use your science and your good
common sense. If it were way out of the range from where you normally operate, it would be wise
to document that.