Repacking of API

Dear all

when we do the repacking of Approved API,(for eg 2no50 kg mateial is repacked to 4no25 kg ),
is it require to analyse the repacked material(4no25 kg ) or the analysis of 2no50 kg material is valid for 4no*25 kg also if the repacking activity is carried out in dedicated facility.what is the expection of regulators.

pl help me in this


2x50kg analysis is sufficient, ( some time customer/ customers ask 5kg ,10kg, 2.5 kg pack … … different for their formulation convenient ,we can’t analysis , each pack / every customer )

Regulator expect you to ensure that product donesnot get contaminated while repacking. You have to justify the same, which can be done by having various checks and controls. If you can prove there is no risk of cross contamination while doing this; it doesnot call for re-analysis.