Quality by Design (QbD) and Analytical Methods - Webinar by GlobalCompliancePanel

21 September 2010, United States

Introduction

As the industry is moving towards applying Quality by Design (QbD) to process development, the question must be asked: Is this also the way forward to revolutionise, improve and standardise our approach to method development and qualification? The pharmaceutical industry has traditionally controlled analytical methods via a well defined sequence of development, validation and transfer exercises in line with agreed standards such as the quality guidelines ICH Q2. Such an approach limits the scope for technological innovation or improvements in quality or efficiency of methods for established products. Applying QbD would enable enhanced method understanding, and a more systematic and scientific approach to development so that better controls may be implemented. This 90 minute webinar looks at the how the QbD philosophy can be applied to analytical methods, resulting in improved method performance throughout the lifecycle of the method in terms of more robust and rugged methods that are designed with the end user in mind. A leaner science and risk based approach to method development and qualification could emerge which would ultimately result in fewer failures when new end users qualify a method and fewer OOS results for routine methods. A QbD approach could move the process of analytical method development and validation into a modern quality system of continuous improvement. The webinar concludes with a comparison of the traditional approach and a QbD approach to method development and qualification.