CGA M-6-2019

$16.90

Standard for Analytical Method Validation

Published By	Publication Date	Number of Pages
CGA	2019-11-07	20

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Category: CGA

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Description

CGA M-6 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.

Additional information