You should not necessarily be locking in on a firm yield range until you have enough history to
know where the yield range should be established. Remember, deviations in yield associated with
critical process steps should be investigated to determine their impact or potential impact on the
resulting quality of affected batches, as per Section 8.1. Thus, it’s got to be a meaningful range.
You don’t want to conduct investigations all the time if there’s no real meaning to it.
