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CGA M-6-2013

Guideline for Analytical Method Validation - 2nd Edition

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 (21 CFR) Parts 211.165(e), 211.194(a)(2), and 820.72(a); and - Chapter 1225 (Validation of Compendial Methods) and portions of Chapter 621 (Gas Chromatography) in the USP–NF.

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