Description: The past few years have seen a heightened global interest by regulatory bodies and user groups in the cold chain for pharmaceutical and biopharma products. The interest has been driven by the establishment of international manufacturing facilities dedicated to serve global markets and a trend towards third party outsourcing for logistics and related services. Like food products, there are unique challenges in creating and managing the cold chain for pharmaceutical and biopharma products. IARW developed a white paper to explore considerations that should be taken into account for these special products.