CGA M-6

Standard for Analytical Method Validation

Compressed Gas Association , 11/07/2019

Publisher: CGA

File Format: PDF

$40.00$81.00


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 Procedures) and portions of Chapter 621 (Gas Chromatography) in the USP–NF.

This publication does not address site specific qualification of a compendial method.

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