Thanks Aleksandra.
Another comment from one of my team:
Bulk hold time will need to be performed in the container that they
would be held in, and this would be real time data and in accordance
with ICH. Depending on what the FPS looks like there may be scope to
reduce the tests performed at this stage.
I have seen shipping studies asked by authorities more and more, however
the extent to which it is performed would have to be justified by the
nature of the product, and the API characteristics are important. Since
I presume these are typical tablet solid dosage forms, I would not
expect there to be extensive shipping studies, however would expect more
from soft gelatin capsules and other friable solid dosage forms. At the
end of the day the applicant should evaluate what environmental factors
will compromise the quality of the product and more important patient
safety!
I have not come across any guidance on the exact requirements of
shipping studies, however, temptails should be used, and also consider
freeze thaw cycles since the temperature in the hold of a plane can
reach very low figures, and likewise depending on the location to which
the product may be shipped, may reach high temperatures, especially if
they get held up at customs. It is not too uncommon for the pallet of
product to be sitting on the tarmac for a few hrs!
With regard to using the Arrhenius equation to predict shelf life, I
have not seen this in the past, however I would be cautious on using
statistics unless the applicant has plenty of data and can demonstrate
and justify such use for prediction of shelf-life. This approach may not
be accepted by all agencies.
Kind Regards,
Pete
Peter Lassoff, Pharm.D.
Vice President, Europe
PAREXEL Consulting
Email: Peter.Lassoff@parexel.com
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