Risk analysis is a key part of Quality by Design (QbD) in the Pharmaceutical and many other industries. Therefore, if QbD is to be applied successfully to the design and use of Insulated Shipping Containers (ISCs) then robust risk analysis is key. There are many places in the design, qualification, and use of ISCs where risks must be identified and mitigated. Much of the risk analysis performed in the pharmaceutical industry is qualitative or at best semi-quantitative. In cold chain applications, however, there are opportunities to apply quantitative risk analysis methodologies. The advantage of this is a better understanding of the risks involved and therefore more effective and efficient risk mitigation strategies.

This presentation describes how a quantitative risk analysis can be applied to the qualification of passive ISCs. In particular it will examine the risk involved in qualifying an ISC using only three replicate tests. The implications of the analysis will be assessed in terms of the latest FDA guidance on process validation and how it might impact ISC qualifications in the future.