when the commercial product is packaged in different packaging configuration, like 1 vial/pack, 3 vials/pack, etc. but drug product inside is the same, only the number of containers are different in each pack type.
ICH Q1D, specifically talks about bracketing of product strengths and not the packaging type. Is it really needed to perform annual commercial stability for all packaging configurations? or any bracketing be applied or any one configuration be picked up.
Pack size, pack type and pack style are main package indicater to performing stability study. Here in this case pack size and pack type remain same so no need to perform stability study . we need to just create separate secondary component to accumulate proudct pack to mainaian thier purity , strength up to thier shelf life.