Dear Luv,
For your first Question,
As per ICH, Where significant change occurs at
the accelerated condition, the shelf life would
depend on the outcome of stability testing at the
intermediate condition, as well as at the
long-term condition.
But as in your case, the product long term
stability is 30 degree & RH 65%. If 30°C ±
2°C/65% RH ± 5% RH is the long-term condition,
there is no intermediate condition required and
hence long term data can suffice the purpose
alone.
Most of the regulatory bodies (Semi-regulated)
will approve the product with such stability data
at 30°C ± 2°C/65% RH ± 5% RH.
Also, mostly Accelerated Stability is normally
required for applications where you dont have
complete real time stability data or your product
is still under development. Because from
accelerated stability data you can extrapolate
the expected shelf life of the product.
For your second Question,
If your product long-term studies are conducted
at 25°C ± 2°C/60% RH ± 5% RH and "significant
change" occurs at any time during 6 months'
testing at the accelerated storage condition,
additional testing at the intermediate storage
condition should be conducted and evaluated. (For
Regulated Market)
The initial application should include a minimum
of 6 months' data from a 12-month study at the
intermediate storage condition.
For exceptions, you have to give a proper
scientific justification to MOH in order to
suppourt your application with exception of not
giving accelerated stability data.
Most of the MOH, may accept only complete real
time data during submissionof application as it
gives the complete shelf life of the product. in
that case, they dont require accelerated
stability data to suppout the application.
As said, earlier, from accelerated data you can
extrapolate the expected shelf life from a real
time (long term) data available at the time of
the application.
Hope this clears, your query.
Thanks
Surender
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