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In Stability testing if significant change occur then what
is the action plan?
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Answer Posted / sitaramaraju kantasputhy
If it is at Development stage, then Formulation change or packaging change shall be done
If it at Exhibit batch study,then that should be addressed as OOT/OOS and same should be investigated.Then shall go for change in formulation or packaging
If it is at commercial batches then same should be addressed as OOS/OOT and should investigated.based on study product should recall.
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