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Zdrowie i gospodarka · 19.02.2014

Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics." This revised draft guidance supersedes the 2000 draft guidance for industry on "Analytical Procedures and Methods Validation" and, when finalized, will also replace the 1987 FDA guidance for industry on "Submitting Samples and Analytical Data for Methods Validation." This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency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.

Source: Federal Register — Food and Drug AdministrationOpen original release →