CGA M-6

Guideline for Analytical Method Validation

Compressed Gas Association , 08/01/2013

Publisher: CGA

File Format: PDF

$48.00$97.00

Description

Standard By:Compressed Gas Association , 08/01/2013

Published:08/01/2013

Language:English

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.