FDA Issues Guidance on Analytics and Method Validation

FDA has issued Analytical Procedures and Methods Validation for Drugs and Biologics, which provides recommendations for how to submit analytical procedures and methods validation data to FDA to support documentation of the identity, strength, quality, purity, and potency of drugs. The guidance supersedes a February 2014 draft guidance, replaces a 2000 draft guidance, and complements the International Conference on Harmonization’s Q2(R1) Validation of Analytical Procedures: Text and Methodology.

The guidance applies to new drug applications, abbreviated new drug applications, biologics license applications, and their supplements, as well as to drug products covered in Type II drug master files.  It does not apply to investigational new drug applications; however, the guidance suggests that sponsors may consider the recommendations in the guidance. Specific method validation recommendations for biological and immunochemical assays for characterization and quality control of many drug substances and drug products are not covered in the guidance.