Recently I had similar problem. We were asked for possibility of
decreasing of transport temperature below 15C for bulk tablets where
statement on bulk product (we buy bulk from suppliers) is::
- store in temperature 15 - 25C
- no special recommendations for the storage
My concern was also - can we correlate data we have for bulk product
in PE bags and paper cartoon tested on stability in conditions
30C/65%. My worry is - what about fluctuations of
temperature/humidity during transport?
For product we develop in R&D I am thinking about doing fluctuation
test during developemnt of project.
I thought about putting product to the fridge for 2 weeks (after this
time: analytical and physical test)
then the same sample will be put to the 30C/65% conditions for 1
additional week and again for next
1 week to the fridge (after this time analytical and physical test).
Do you think is it good idea?
Should it be accepted by auditors?
The most important for me will be our safety, that product after
fluctuations have the same quality.
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Kate
katarzynag@biology.pl
Generic company
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