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Guidance on Analytical Procedures/Methods Validation


Federal Register Notice: FDA is making available a guidance for industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics. It supersedes the draft of the same name that published on 2/19/14 and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and the 1987 FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation. This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. To download this guidance, click here. To view this notice, click here.