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full name of OOS & OOT ? Dercribe it with details ? why
this is needed in pharma industry ?
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Answer Posted / narendra
OOS- out of specification .it means any result
not meet in specification limit or guideline limit.
Exp.-Limit 95-100 % Result obtain 110 % -OOS
OOT- Out of trend . any product batch made in single time and we analyzed time to time as per stability chart scheduled ,if stability result that is not
within the expected trend, with respect to previous/Initial
station results obtained during a stability study.
EXP.- PARACETAMOL TAB. RESULT -
Month %
0 100
6 95
12 98
24 101
36 97
48 115 - OOT
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