I recently attended a temperature and logistics conference where one of the QPs laid down the science and theory behind temperature control of pharmaceutical products and active ingredients. The complicated science is based on the Arrhenius equation of K=Ae-Ea/(RT)
Yes, it was all rather scary. But fear not, I will spare you the complicated explanation and opt for a simple explanation. Essentially all pharma products and active ingredients consist of molecules that operate optimally at or within a given temperature range. As the temperature increases or falls out of this range, the molecules of the product or active ingredient start to collide in an unacceptable manner leading to a change in scientific structure and therefore a change in the effectiveness of the product. This ultimately leads to product degradation. This could no doubt affect patient safety and ruin a perfectly genuine product.
Currently GDP requires temperature control of pharma product and active ingredient. However, as the awareness of temperature control and stability increases, it may be a matter of time before we need to apply and consider temperature requirements for excipients too.
So its best we get temperature control right as soon as possible. Carry out all necessary validation tests and assessments on your packaging, transport routes and the logistics provider. Bear in mind: outsourcing the transportation of the product does not relinquish your responsibility as the WDA holder. You should be able to justify the chosen means of transportation; outsourced or not! The same applies if the sale or supply is based on an Ex Works model. Allowing the goods to be picked up by your customer in a ‘dodgy’ MOT failing, temperature-uncontrolled vehicle will most definitely not be acceptable to GDP standards. So make sure your TAs specify what you expect and what you will not allow!
