A quick cold chain question: Should product transport temperature conditions be the same as the storage conditions i.e if a product is stored at 2-8 should it be transported at 2-8?
Currently we store at 2-8, but during shipping are allowed 0-25 for 48hours. I guess we have stability data to justify this. I heard that the EMEA were going to propose that transport temp should be the same as storage temp.
The actual transport conditions should be same as the storage condition however the spikes are allowed for a certain time period. MKT should be the backup data for the same…one can also have the stability / Process chemistry / Thermal stress testing data for the product to justify the certain spikes to make the study as validated.
You may refer the USP general Chapter 1079 for further details… PDA had also published one technical report on the same refer TR : 46.
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