The ISTA Pharma Committee and Shipping & Distribution Risk Assessment Working Group have prepared this white paper to provide an overview for developing a Shipping and Distribution Risk Assessment (RA) for the distribution of temperature-sensitive product shipments. The team sought to define the critical aspects associated with completing a shipping and distribution risk assessment; from establishing/understanding the user requirement specifications (URS) through implementation. The content and examples provided in this document are to be used for general industry guidance and awareness to drive a standardized best practice approach for conducting Shipping and Distribution Risk Assessments.