Developed by members of the ISTA Pharma Committee, this technical white paper discusses the operational qualification of passive thermal packaging systems for temperature-controlled distribution of pharmaceutical and biological products.  The intent of this information is to establish an aligned industry best practice for the operational qualification testing of passive thermal packaging to transport temperature-sensitive medicinal products.  The level of detail beyond the suggested industry best practice is a decision, based on the risk acceptance of the primary stakeholders of the temperature-sensitive product.  Thus, the examples given are for demonstration purposes only and may be more or less detailed than what is discussed in this paper.