Enhanced Approach of Analytical Method Development & Analytical QbD in Different Phases of Clinical Development

It is a common issue during the pharmaceutical development life-cycle that analytical development and related validation/transfer activities are becoming the critical bottlenecks for progress. This typically occurs due to unrobust analytical methods as a result of poor method development and performance evaluation strategies and lack of implementation of analytical procedure lifecycle approach. Development using an enhanced approach and QbD principles have been gradually becoming an industry standard in manufacturing process development and is being encouraged by regulators. QbD as a risk- and science-based approach should also be exploited in the analytical development and validation areas as implicitly suggested by the recently published ICH Q14 and ICH Q2(R2) guidelines. An enhanced approach of analytical procedure development and an appropriate implementation of analytical procedure lifecycle approach contributes to analytical methods of higher robustness. As a result, higher quality data is available to support control strategy development, process understanding and process capability assessments. Additionally, fewer quality events during release- and stability testing can be expected resulting in reduced regulatory risks, lower costs, higher sample throughput and shorter cycle-times on the long-term.

This session is recommended to all those process chemistry and analytical professionals who would like an insight into the practical implementation of an enhanced approach of analytical procedure development and analytical procedure lifecycle, with special emphasis on phase-appropriate strategies during development.

This webinar was presented by Dr Balázs Klencsár