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AOAC® PERFORMANCE TESTED METHODSSM PROGRAM

The AOAC Performance Tested MethodsSM (PTM) program began in 1992 and has evolved into a premier method certification program for proprietary methods. Methods certified as Performance TestedSM were found to perform according to the manufacturer’s documented claims and are used throughout the global market place and within the regulatory arena. The PTM program offers certification as an endpoint for method evaluation or as an entry to method validation for programs requiring increased confidence and method reproducibility information. PTM certification includes licensing the method developer to use the Performance TestedSM certification mark.

Program
Steps

Step 1: Application Process

The first step towards PTM certification is to submit a completed PTM Review Application to the AOAC Research Institute. The required documents for submission include:
  1. Completed PTM Review Application;
  2. Method Package Insert(s), Method User Instructions, or Method User Guide(s);
  3. Method Packaging Labels;
  4. Manufacturing QA/QC Synopsis; and
  5. Formatted Method Developer Validation Study Report (if available);
  6. Proposal for Independent Laboratory Testing Protocol (if RI Consulting Service is not used).

Step 2: Independent Laboratory Testing Process

Independent Laboratory Study is a verification of evaluated performance claims and method applicability. It requires an agreement between AOAC Research Institute and the selected laboratory. Independent laboratory studies require AOAC approved testing protocol(s). Only AOAC Research Institute communicates with the independent laboratory. All other types of communication must be facilitated through the AOAC RI. AOAC Research Institute maintains a list of eligible independent laboratories on the AOAC website for consideration.

Step 3: Expert Peer Review of Data

The method developer compiles the method developer study (single laboratory validation or SLV) and the independent laboratory study into a formatted manuscript. Completed manuscripts and method package inserts/user instructions are submitted to AOACRI, which then facilitates the peer review process of the manuscript. Manuscripts are reviewed by a three (3) program volunteer expert reviewers. The reviewers examine the independent data and the SLV data. Reviewers also evaluate the data against the proposed method applicability and the package insert information. Manuscripts may be revised based on reviewer comments. After two cycles of review and comment, the reviewers are required to render their recommendations for approval.

Step 4: AOAC Performance TestedSM Certification

If the experts concur on their recommendation to approve, then the Research Institute grants AOAC Performance TestedSM certification for that method. Certification involves signing a Certification Mark License Agreement. Organizations signing this agreement are licensed to use the AOAC Performance TestedSM certification mark that includes the specific certificate number for the method being certified. In addition to the Certification Mark License Agreement and the certification mark, organizations also receive a certificate with the method specific certification number, and information regarding publishing the validation manuscript and method information in the Journal of AOAC INTERNATIONAL and in the AOAC INTERNATIONAL’s Inside Laboratory Management. All certifications are good through December 31st of each year.

Step 5: Annual Review and Certification Renewal

Certifications are annually reviewed and renewed on a calendar year cycle from January 1st through December 31st. Method developers apply for recertification and attest that no changes have been made since the last certification or original validation. Documentation is reviewed to confirm no variation was made. Once clearing this review, a new certificate is granted for the next calendar year. Method developers submit the following documents:
  1. Package insert or user instructions
  2. Product labels
  3. Signed Certification Mark License Agreement (if necessary)
  4. Any new performance data to support claims such as lot-to-lot and/or stability data

Fees:

PTM application fees:
  • $21,000.00 USD per method for Non-Contributing Members
  • $15,000.00 USD per method for Contributing Members
A $500 discount will be applied to the PTM application fee when consulting services are requested.
To access the form, please click PTM Review Application or visit the AOAC website, click on Research Institute -> Method Submissions tab.

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