CGA M-6 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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Edition: 3rd Published: 11/07/2019 Number of Pages: 13 File Size: 1 file , 630 KB