Publication Details

[M-6] Guideline for Analytical Method Validation


Title Guideline for Analytical Method Validation
Edition 2
Published August, 2013
Status Available to the public
Size 13 pages
Publisher CGA
Special Attributes
Committee Medical Gases


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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