finished product analysis Contribution from Deepak Kheni written on 8/30/2010 at 14:19
Dear all,
Which stage of product should be considered as Finished product
incase of Solid Oral dosage form (Tablet)? whether Uncoated / Coated
tablets or packed? If product is coated and analysed at coating stage,
is it necessary to analyse again after packing since there will not
be any physical change in product? Moreover, stability studies are performed with finished pack only which already proved that product is safe and meeting all the specification throughout the shelf life. What is industry's standard practices? How regulatories are taking the matter? Is there any clear cut gudeline OR rules available?
Thank you very much
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