What will be in case stability sampleWhich have batch but
distribute in three country.In tath case< we can put the
sample for all country, whenevr all have same temp(Zone)
Answer Posted / ali mostafa
You should check the mean temperature/Humidity of the
country the product will be sent, and according to that
adjust the stability program.
If the three countries have the same climate zones,and we
have a good stability results for that zone (from ICH
guidelines),we can put the sample for all three countries.
Is This Answer Correct ? | 3 Yes | 2 No |
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