Section 12.1 of Q7A states, “The critical parameters/attributes should normally be identified
during the development stage or from historical data, and the necessary ranges for the
reproducible operation should be defined”. Normally, the full range of processing parameters that
are listed in the filing are wider than those challenged during validation. These ranges are
normally established in the development lab or in the pilot plant to show that acceptable product
can be manufactured. Many companies chose to operate within tighter ranges (e.g., target
process parameters, typical ranges, etc.) during routine production.
