1. INTRODUCTION

The extent of physicochemical degradation of drug products depends on factors such as product stability to include how a product is stored. Storage and holding areas need to maintain labeled temperature ranges to ensure product efficacy and expiry. Many factors impact the ability of a drug storage area to maintain acceptable temperature ranges (see Packaging and Storage Requirements 〈659〉), including airflow, heating and air conditioning, wall and ceiling insulation, doors, traffic (e.g., frequency and time that doors are open), geography, and orientation of the physical structure.