Proper Disposal Of Investigational Products In Clinical Research: Regulatory Framework, Operational Guidance And Environmental Stewardship

Abstract

Proper management and disposal of investigational products (IPs) in clinical trials is essential for participant safety, data integrity, regulatory compliance (Good Clinica Practice &Good Manufacturing Practice), and environmental sustainability. This review synthesizes evidence from environmental science, clinical trial guidelines, and biomedical waste management literature to provide a holistic framework for cradle-to-grave stewardship of IPs. Key topics include environmental risks of pharmaceutical pollution, global regulatory guidance, operational procedures for return and destruction, documentation practices, and strategies to minimize ecological harm with gaps and future directions.