12. Method Development

A general framework for method development based on the analytical quality by design process is presented and applied to the development of near-infrared spectroscopic methods. The framework is particularly well suited to secure stakeholder alignment, setting appropriate expectations and ensuring that resources are spent appropriately. After setting method goals and expectations and confirming feasibility, a risk assessment is performed to identify all the factors that could affect the method. The method is then developed with the intention to mitigate the impact of those risks. The result is a robust method that can be tested and validated if required by the regulatory environment of use. Aspects of method lifecycle are also discussed as method development is only a part of the process of successfully using near-infrared spectroscopic methods in routine commercial applications. Aspects of interface to the process, sample set selection, model optimization, system suitability, and performance monitoring are discussed in the context of building robust methods. The analytical quality by design framework can significantly streamline method development and lifecycle management efforts to ensure a successful deployment and long-term value generation from a NIR spectroscopic method. Continuous improvement ensures method performance over the useful life of the method.