Standard

CGA/GAS M-6

Published

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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) [2]; and • Chapter 1225 (Validation of Compendial Procedures) and portions of Chapter 621 (Gas Chromatography) in the USP–NF [1]. This publication does not address site specific qualification of a compendial method.

Document information

  • Standard from CGA/GAS_AC
  • Published:
  • Version: 0
  • Document type: IS
  • Additional information
    • THIRD EDITION