Publication Details

[M-6] Guideline for Analytical Method Validation

Properties:

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


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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