Chapter 3 - Analytical quality by design for gas chromatographic method development

Abstract

Quality by design (QbD) is a scientific approach in pharmaceutical product development beginning with predefined goals and utilizes scientific knowledge and risk management tools to understand the process/product and finally process control. The change in mindset of a research professional from quality by testing to QbD is a significant trend in analytical sciences for the future. QbD has the potential to be extended to analytical techniques such as gas chromatography (GC) to achieve optimum analytical method performance. GC is a sensitive, consistent, and versatile technique applied to analyze complex mixtures and drugs as well as pharmaceutical products. Application of analytical QbD principles to GC encompasses all the essential steps including GC method development and validation. This chapter outlines the application of QbD concepts to analytical separation method of GC along with utilization of risk assessment and design of experiments. It further offers a greater understanding and recognition of GC variables influencing the performance of its method enabling an enhancement in quality.