RE: RE: finished product analysis Contribution from GK Kalpathi written on 8/30/2010 at 17:21
Original contribution: RE: finished product analysis written by Vamshi on 8/30/2010 at 15:21) The product in its primary market pack is termed as finished product. Uncoated tablets can not be the finished product if the coated tablets are the marketed product.
Tablets can be packed in bottles or blister or foil or bulk (in case of exports to customers who then repack into consumer packs). There can be several pack sizes.
The ICH guidelines on stability gives more details on what should go into stability studies as well as offers some relief in the form of using bracketing of pack sizes (Q1A to Q1F).
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