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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)
- 5 Answers
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Answer / shoukatalli
Stability of sample doesnot depend on material you had sent
in different coutries.you should carry long term stablility
of only one retained sample as per ICH guidelines (temp and
humidity conditions).
| Is This Answer Correct ? | 9 Yes | 1 No |
Answer / kishor solanke
Stability testing does not depend upon their standard of
release e.g. EP, USP, JP or what ever it may be OR where u
had sent these batches If their MKT are same & no change in
their requirement conditions then only same samples can
represents the stability for all countries.No need to
charge saperately.
| Is This Answer Correct ? | 2 Yes | 0 No |
Answer / 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 |
Answer / parag
Depending upon the mean kinetic temperature we have to put
and analyse the sample for the three countries seperetly
| Is This Answer Correct ? | 1 Yes | 1 No |
Answer / sumit tyagi
If all three country having same climate zone or same container closer is used for all three country then only single sample study represent the result for all three country.No required charged Sample separately.
| Is This Answer Correct ? | 0 Yes | 0 No |
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