ABSTRACT
Stability of quality attributes may affect a drug product’s safety and efficacy over its labeled use period (shelf life). Effective utilization of stability testing plays a critical role throughout the life cycle of a drug product. During early development, well-designed stability studies can help gain a deep understanding of the product’s degradation pathways. In late phase development, stability testing provides information regarding how a variety of environmental factors such as temperature, humidity, and light affect the product quality over time. These data are also used to establish the shelf life and storage conditions of the product, in support of regulatory licensure. For marketed products, stability studies can be used to (1) update shelf life or release limit(s), if needed, to warrant product quality through a specified (shortened or extended) period; (2) provide assurance of robustness of the manufacturing process after process changes (including site, scale, formulation, storage, shipping conditions, and delivery device); and (3) aid in the evaluation and removal of non-stability-indicating tests. As the entire pharmaceutical industry is moving toward a risk-based paradigm for process and product development, full utilization of stability studies has become increasingly important not only in increasing product quality assurance but also in minimizing the risk of untoward rejection of good product lots or acceptance of compromised lots.
