What are the requirements for shipping products?December 12th, 2012 by Peter Calcott
Pharmaceuticals are notoriously heat labile; at least many of the new high tech ones. Many require cold temperature storage at 2-8C. While they can withstand higher temperature for short periods of time, the shelf life of the products is defined by the recommended storage temperature of 2-8C.
With that understanding, is it acceptable to routinely ship them at elevated temperatures eg. ambient? Think of the money we could save says your friendly distribution staff.
This was the question posed to me recently in a webinar hosted by The Tungsten Shield Group on Cold Chain Distribution.
The European regulations are clear. The transportation temperature must be the same as the recommended storage condition. Distribution is really moving storage. Thus, a product designed as requiring cold storage, also requires the same cold condition for distribution. It is clear.
However, the FDA is particularly silent on this in regulations at least. However, they do expect transportation conditions to equal the storage conditions. Thus even the FDA does no condone this practice.
Both regulatory bodies recognize that things go wrong. A shipment heats up due to delays beyond the validated time. Patients leave the drug on the dashboard of the car for hours. These things happen. And a robust stability program designed to explore the impact of elevated temperatures can come to the rescue to determine if the abnormal conditions have degraded the product or not.
However, these accelerated conditions hsould not be used to justify a save a buck program that puts product in jeopardy.