If we are reducing the no of lots (from 4 lot to 3 lot) in granulation.Then it is coming under which type of change according to SUPAC. Validation required for all the stages or only granulation is acceptable.
This change is minor because it will not have any impact on product quality. Validation of granulation part is enough but auditor may have an objection and ask for validation of the whole process that will require a proper justification for the same.
Dear sir please explain me Why bulk density and tapped density and particle size distribution is required in garanulation stage