FDA Releases Revised Draft Guidance On Methods Validation for Pharmaceuticals

The Food and Drug Administration is releasing a revised draft guidance for industry on analytical procedures and methods validation for drugs and biologics, according to a notice published in the Feb. 19 Federal Register (79 Fed. Reg. 9,467).

The revised draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity and potency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, the agency said.

The FDA said the revised draft guidance supersedes the 2000 draft guidance for industry on “Analytical Procedures and Methods Validation” and, when finalized, also ...