Application of a Degree-Hour Approach for the Management of Over-Temperature (OT) Excursions for Investigational Medicinal Products (IMPs) and Non-Investigational Medicinal Products (NIMPs) | IVT

This publication describes how to convert degree-hour measures of over-temperature (OT) allowances to hours within a defined temperature range.  Additionally, it will be shown how to derive the appropriate Hour Conversion Ratio (HCR) to convert a number of hours in a higher temperature Tier to an equivalent number in a lower Tier for accounting purposes.  Finally, the division of Tiers into smaller Mini-Tiers is described.  Mini-Tiers are used to provide a finer granularity which allows more economical "expenditure" of the allocated OT allowances.