Paul Daniel

Jul 25, 2018
Dear Rocio:

There is some good guidance around this topic from the USP, which I will share later.

As far as actual “legal” regulations, this will depend very much on which countries you do your shipping and transportation activities in. The GDP (Good Distribution Practices) vary widely from country to country. My best recommendation is to look at the regulations for both the country(s) where you manufacture your product as well as the countries that receive your product. Start there and you will be able to tell what set of regulations legally apply to you.

Now back to guidance. For a starting point, try the USP Revision 36 Chapter <1079>. It touches on qualifications of vehicles for transportation of pharmaceuticals and medical devices.

In the end, much of this boils down to your expected use cases. If your products will be in the truck for no more than 24 hours, then should do your test for at least 24 hours. This duration should be the same for both loaded and unloaded conditions.

Good luck and thank you for reading our blog!

Paul Daniel