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Why do test methods need to be validated?

April 26, 2017methods Test validated

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Why do test methods need to be validated?

1 Answer

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Current Good Manufacturing Practice 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.