Batch size

As per WHO process validation must be performed for 100000 units, if suppose to be manufactured 2500 units and apply for COPP, but query raised by drug inspector “batch size not consistent as per guideline”

Comment from By CIDSCO: Batch size for PVSS is not consistent with the WHO-TRS guideline for OSD forms.

What will be technical answer or validation perform for 1 lac and submit the 6 month data (wait)