Standard

CGA/GAS M-6

Publisert
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Omfang

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.

Dokumentinformasjon

  • Standard fra CGA/GAS_AC
  • Publisert:
  • Versjon: 0
  • Varetype: IS
  • Tilleggsinformasjon
    • THIRD EDITION