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AOAC Research Institute Policies and Procedures
© 2009 - AOAC Research Institute
1
POLICIES and PROCEDURES
1.
Purpose
The
Performance Tested Methods
SM
(PTM)
program provides an independent third-party
review of proprietary test method performance. Test methods demonstrated to meet
acceptable performance criteria are granted PTM status. Method Developers of approved
PTM
test methods are licensed to use the PTM certification mark. The PTM certification
mark assures users that an independent assessment has found that the test method
performance meets an appropriate standard for the claimed intended use.
2.
Background
The AOAC Research Institute (RI) was incorporated in 1991 as a nonprofit subsidiary of the
AOAC INTERNATIONAL (formerly know as the
Association of Official Analytical Chemists)
.
The AOAC Research Institute operates as an independent corporation with its own Board
of Directors and dedicated staff.
The mission of the AOAC Research Institute is to promote and carry out activities related to
the development, improvement and validation of proprietary methods. A list of currently
approved methods can be found at the AOAC Research Institute website at
http://www.aoac.org/testkits/testedmethods.html .The AOAC Research Institute cooperates with many US and international organizations
including: US Food and Drug Administration, US Department of Agriculture; US Department
of Homeland Security; US Department of Defense; US Environmental Protection Agency;
Canadian Food Inspection Service, Health Canada; Association française de
Normalisation; Nordic Committee on Food Analysis; MicroVal; and the International
Organization for Standardization.
The PTM program is designed to be complementary to the
Official Methods of Analysis
SM
(OMA) program. The PTM evaluation can serve as the OMA “pre-collaborative” study for a
microbiology method; or as the single laboratory validation for a chemistry method.
3.
Overview
The PTM program has six distinct phases:
1)
Consulting
2)
PTM Application
3)
Method Developer Validation Study
4)
Independent Validation Study
5)
Validation Study Report
6)
PTM Review