CGA - M-6
GUIDELINE FOR ANALYTICAL METHOD VALIDATION
| Organization: | CGA |
| Publication Date: | 1 January 2013 |
| Status: | inactive |
| Page Count: | 17 |
scope:
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 Methods) and portions of Chapter 621 (Gas Chromatography) in the USP-NF [1].
Document History