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In Stability testing if significant change occur then what
is the action plan?
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Answer / 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.
| Is This Answer Correct ? | 26 Yes | 1 No |
Answer / mihir
IF MAJOR CHANGES IS OCCURE THAT TIME CHANGE IN FORMULATION
IS DONE BEFORE THAT IF OUR PRODUCT FAILS IN ACCLERATED
STABILITY STUDY THEN WE ONCE GONE THROUGH WITH LONG TERM
STABILITY STUDY, AFTERWORG MAJOR CHANGES IS OCCURS THEN
REQUIRED CHANGES IN FORMULATION NECESSARY.
| Is This Answer Correct ? | 5 Yes | 1 No |
Answer / fareena
if major change is occured during stability studies then
change in the formulation can be considered n change in
existing pkging material as well.
| Is This Answer Correct ? | 3 Yes | 2 No |
Answer / dharmpal
change the formulation and keep temperature and humidity
| Is This Answer Correct ? | 3 Yes | 11 No |
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