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Why do test methods need to be verified or validated?
Current Good Manufacturing Practice (cGMP) regulations [21 CFR 211.194 (a)] require that test methods, which are used for assessing compliance of drug products with established specifications, must meet proper standards for accuracy and reliability. In addition, microbiological test methods may require validation per pharmacopoeia (USP, EP, etc) requirements. Please inquire with our sales department regarding the cost of method validations.