Analytical methods must undergo validation or revalidation before their incorporation into routine analyses, particularly for batch release. To incorporate quality attributes into the analytical method, bench-level scientists must apply fundamental quality principles. This paradigm shift necessitates that bench-level scientists possess scientific and technical expertise, product knowledge, process knowledge, and/or risk assessment skills to effectively execute the quality functions of analytical method validation. ICH addressed was the validation of analytical procedures. The ICH has developed guidelines for the validation of analytical procedures. These guidelines are intended to ensure that analytical procedures are accurate, precise, specific, and reproducible. The important parameters for method validation are calibration curve, specificity, limit of detection, limit of quantitation, accuracy, repeatability, and reproducibility. All these parameters have been discussed in this chapter in excel spreadsheet format.