Matching Environmental Monitoring & Mapping to FDA/ICH Guidance for Better Stability Studies

Overview:

Matching Environmental Monitoring & Mapping to FDA/ICH Guidance for Better Stability Studies

A critical and often overlooked step of pharmaceutical production, research and development is stability testing and monitoring. Stability testing and monitoring affects how pharmaceuticals are produced, packaged, labeled and sold. This application note discusses proper protocol and practices of effective stability testing and monitoring to comply with regulatory bodies such as ICH and the FDA.