This publication describes the minimum requirements for validating noncompendial analytical test methods. It also describes a method for establishing the equivalency of alternate test methods.
This publication is intended to meet the requirements of:
- Title 21 of the U.S.Code of Federal Regulations(21CFR) Part 211.165(e), 211.194(a)(2), and 820.72(a)(2); and
- Chapter 1225(Validation of Compendial Methods) and portions of Chapter 621(Gas Chromatography) in the USP-NF[1].