ABSTRACT
The suitability of compendial microbiological methods must be demonstrated by the user to ensure accuracy and reliability of test results. This topic is addressed by the United States Pharmacopeia (USP) in the following chapters:
Chapter <1225>, Validation of Compendial Methods-According to section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specications in monographs of the USP and the National Formulary constitute legal standards. The current good manufacturing practice (cGMP) regulations [21 CFR 211.194 (a)] require that test methods, which are used for assessing the compliance of pharmaceutical products with established specications, must meet proper standards of accuracy and reliability.
