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A new drug substance found fail to meet specification for
an unknown Impurity during stability study(Specific
change),how would further proceed?
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Answer / vikas kumar
Firstly it was not clear on which condition we are getting
the OOS and at which time point.
It it was failed in Accelerated condition than we have to
look definately for intermediate condition for 12M.
if it was in long term condition than we have to firstly
raise the OOS and and proceed as per OOS procedure similary
we can check wether the method was stability indicating or
not.
| Is This Answer Correct ? | 4 Yes | 1 No |
Answer / chinna
if the sample failed in accelerated condition we go for long term storage condition.if it fails in long term stability we go for OOS and give to retest/Expiry as per ICH guideline
| Is This Answer Correct ? | 1 Yes | 0 No |
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