Validation of Analytical Test Methods

The generation of high-quality analytical data is imperative in the effective knowledge generation and development of new medicines. Analytical methods are the tools that generate data are used to make fundamental development decisions, and validation demonstrates that methods are fit for this purpose. This chapter describes the parameters that should be investigated during the development of a pharmaceutical drug, from early development to commercial product. As a product continues through development, increased knowledge of the chemical and physical properties of the drug and the drug product is gained. Consequently, the validation requirements of analytical procedures become more complex and comprehensive, and a suitable strategy is described. The method validation parameters described in regulatory and compendial guidance that generally apply to commercial products are discussed, together with current concepts such as quality by design of analytical methods, in silico tools, validation of automated procedures, and example acceptance criteria for chromatographic procedures.