| |
| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-06 | VERSION NO.:2.3 | Section 6 ORA Method Development and Validation Program | EFFECTIVE DATE: 04/02/2004 | REVISED: 12/03/2008 |
6.2 Purpose
The goal of this program 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 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.
|