The ICH member regulatory authorities require submission of analytical methods validation data as part of registration applications. The ICH guidelines Q2 (R1&R2) Validation of Analytical Procedures: Text and Methodology, presents general considerations for analytical method validation study. Pertinent guidelines such as ICH Q3A (R2), ICH Q3B (R2) and ICH Q3C(R9) for Impurities in New Drug Substances, Impurities in New Drug Products and Guideline for Residual Solvents, respectively, are followed.
