Facilitating Analytical Procedure Changes via ICH Q14

The ICH Q14 guideline provides a science- and risk-based approach to developing and maintaining analytical procedures, ensuring they remain fit for purpose throughout a drug’s lifecycle. However, implementing changes to analytical procedures remains complex due to regulatory variations across global markets. The adoption of ICH Q14, alongside principles from ICH Q12, offers the promise of a streamlined postapproval change management process that reduces regulatory burden while maintaining compliance. This interactive workshop organized by the ISPE PQLI ICH Q2(R2)/Q14 Analytical Method Strategy team will explore how analytical procedure changes can be facilitated through case studies on method changes, column and instrument transitions, platform method adaptations, and the utilization of established conditions (ECs) and post-approval change management protocols (PACMPs). These examples highlight how the use of risk assessment and performance-based criteria streamline post-approval changes while ensuring robust product control. By leveraging ICH Q14’s flexible framework, companies can integrate new technologies, improve laboratory efficiency, and ensure pharmaceutical quality in an efficient manner. The ultimate goal is to enhance innovation, optimize supply chains, and deliver safe, effective products to patients faster.