Q2(R1) Validation of Analytical Procedures

International Conference on Harmonisation (ICH) Q2(R1) provides a formal overview of the criteria required to fully validate an analytical procedure. It highlights that the purpose of any method validation is to demonstrate that it is “suitable for its intended purpose”. This is a theme of this chapter, as too often there is a slavish desire to follow the guideline without truly understanding the strengths and weaknesses of the method that has been developed. The chapter discusses some of the benefits of developing methods using quality by design (QbD) approaches. The chapter also explores a framework for applying QbD to analytical methods. It further explores examples of validation of the analytical methods, for example, near-infrared spectroscopy (NIR), and demonstrates that this guidance is equally applicable to non-chromatographic methodologies. Finally, it is important to recognize that medicinal products are developed transnationally, with products being moved across global manufacturing networks.