• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Science & Research

  • Print
  • Share
  • E-mail

Volume III - 6.2 Purpose

DFS Pyramid Logo

Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-06

VERSION NO.:2.7

Section 6 ORA Method Development and Validation Program

EFFECTIVE DATE:
04-02-04
REVISED: 01-09-14

The goal is to satisfy the need for regulatory analytical methods meeting current and anticipated public health program needs and agency priorities. This Laboratory Manual section provides the procedures for the identification, development, submission, review and publication of method protocols, validation studies, method extensions or other research studies. The procedures assure that projects meet regulatory needs, accomplish their intended purpose, include validation for Agency-wide distribution (where appropriate and/or in conjunction with the Office of Foods), and become meaningful analytical tools for use. Additionally it provides scientific conduct guidelines for the program and encourages and enhances the creative skills of talented scientists in ORA Laboratories.