Publication
M-6: Standard for Analytical Method Validation
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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Edition:
3
Published:
November 2019
Status:
Available To the Public
Size:
13 pages
Publisher:
CGA
Special Attributes:
Notes:
Committee:
Medical Gases
Related
M-4