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.
- 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.
CGA M-6 History
More Standards PDF
CSA Z62.3-11 (R2021)
$68.00 $137.00
CSA ANSI Z21.13b-2012/CSA 4.9b-2012
$61.00 $122.00
CSA B125.2-11/ASME A112.18.2-2011
$40.00 $80.00
CSA C22.6 No. 1-11 (R2019)
$68.00 $137.00