RE: Out of Specification Contribution from Sesham Raju written on 2/1/2012 at 07:58
Original contribution: Out of Specification written by Karthik on 2/1/2012 at 07:18) Karthik,
in simple terms OOS starts in laboratory and ends in production.Investigation in Laboraroty is Phase-1 for any error identification or Investigation in production Phase-2 ( full investigation). MHRA guideline on OOS and FDA are good.
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