Paul Daniel

Jul 28, 2020
Hi Jason:

Here's a quick answer. All countries (to my knowledge) require temperature specifications for drug products and will expect that your drug products will be maintained within those specifications. And all countries will consider your drug products to be "adulterated" if they are not stored at those defined specification, and they will expect that adulterated product will be disposed of and not sold. This creates a condition where it is in a manufacturer's best interest include in their storage specifications a definition of an acceptable excursion (in terms of time and temperature).

Then there's the curious thing about cGMP (current Good Manufacturing Practice) in that you need to stay "current", which in practice means your quality processes are compared to those of your peers, and you are expected to keep up. So if everybody else is doing it, you are expected to do it to (or have a good reason why you don't).

So, offhand, I don't know of a specific regulation that says you need to have a well-defined excursion policy. I just have never encountered a modern drug manufacturing facility with a temperature sensitive product that didn't have a well-defined excursion policy.

I hope this helps! Feel free to contact me directly if you have more questions.