Publication

M-6: Standard for Analytical Method Validation

Abstract

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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Properties

Edition:

Published:

November 2019

Status:

Available To the Public

Size:

13 pages

Publisher:

CGA

Special Attributes:

Notes:

Committee:

Medical Gases

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M-6: Standard for Analytical Method Validation

Abstract

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