A Quality by Design Approach to Chromatographic Method Development

Quality by Design (QbD) has recently been advocated by the FDA and applied to the development and manufacture of drugs within the pharmaceutical sector. In efforts to ensure consistent quality and performance of drugs, ICH guidelines1 and recommendations encourage pharmaceutical companies to improve process control by adopting a QbD approach early in drug development.

Understanding how QbD applies to the development of chromatographic methods, as a process, requires a closer look into the architecture of method design, the influence of input variables on critical output measurements, and use of modern software tools to support QbD objectives. Practical implications of QbD include modelling the influence of variables on quality, design of experiments and refinement of processes as information is collected.

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