Excipient Usage Technical Risk Assessment for Generic Solid Dose Products

Abstract

This paper proposes an assessment methodology for solid dose generic small molecule drug products. It addresses the ‘usage of the excipient’ portion of the trinomial by utilizing the systematic approach of Risk Identification, Risk Analysis and Risk Evaluation as per ICH Q9 Quality Risk Management outlined for developing risk control strategies. The assessment and maintenance of excipient risk profile is essential to minimize any potential risk associated to excipients impacting patients.