Zdrowie i gospodarka · 27/07/2015
Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics." This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on "Analytical Procedures and Methods Validation" and the 1987 FDA guidance for industry on "Submitting Samples and Analytical Data for Methods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.