In Stability testing if significant change occurs then what
will be the action plan?
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Answer / udaya
if significant change occurs in stability studies, we have to select subsequent condition means if we observe significant change in long term then go to refigerator condition as it is if accelerated condition then go to intermediate continue the which month you are observed significant change. if these conditions also significant change occurs then change the packing condition of sample if we are packed the sample in outer black and inner double polythene white bag then go to keep silica gel otherwise TLMB bags like this.
| Is This Answer Correct ? | 6 Yes | 1 No |
After closing the investigation against the significant
change occurs in which condition, then go to further
stability testing conditions, ie if accelerated conditions
having significant change then go to Intermediate
conditions, if Long term conditions having significant
change then go to Refrigerator conditions.
| Is This Answer Correct ? | 3 Yes | 2 No |
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