RE: RE: Overage Contribution from JD Mallet written on 1/19/2012 at 21:09
Original contribution: RE: Overage written by g.joseph on 1/19/2012 at 09:24) Dear Mahfuz,
Typically the role of an overage is for compensation of the active ingredient losses that can occur during the production. Some would formulate products with an overage to "prolonge" their shelf-life.
Here there are some cultural discrepancies considering the practice of overaging. The "European" culture is mainly that overages are only to compensate losses while, at a certain extent, the US culture would tolerate some overaging to enhance the shelf-life.
Anyway, the % of overaging should be part of the MA dossier and should not be decided later in production.
Any other experiences from the Forum ?
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