What is the procedure for investigation of an OOS (Out of
specification) results?
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Answer Posted / rams
OOS Investigation done by groupleader ,firstly wether check
analyst follow the correct STP ,check the analysis he is
done e.g. he used proper cleaned glassware and correct
working standard ,he used calibrated system like Ph
meter,Dissolution,HPLC and also correct dilutions .If he
done correct analysis,then give same sample for 2nd analyst
for OOS analysis.
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