Allergens ERP Book, Sept 17

The basic requirements for selection of methods for further validation studies will be: fitness for purpose, applicability to the scope needed, clarity of method description, satisfactory performance characteristics, and single laboratory validation data. To assist the Panel, the AOAC will provide a “Methods Selection Worksheet,” which may be modified at the discretion of the ERP. ERP members will identify the best method(s) for further validation, and identify any modifications to be made to the method. An example of the Method Selection Worksheet is attached. Samples: The ERP will be asked to recommend the specific materials (matrices) to be included in the subsequent validation studies, along with detailed justifications. Summary Report: The Chair of the ERP prepares a Summary Report clearly enunciating the recommendations of the Panel, the manner in which these conclusions were reached, any modifications of the method(s) chosen, and the materials (matrices) to be included in the validation studies. The report is to be submitted to the ERP in a timely fashion after the concluding ERP meeting. Comments are also due back to the ERP Chair in a timely fashion. The report is then sent to the stakeholders and a copy is forwarded to the Chair of the OMB. Post-ERP Activities: AOAC retains the right to call on the panelists, as well as members of the Industry Groups, for continued assistance in the subsequent validation studies. This may include (1) help in obtaining the required samples for use in the subsequent validation studies, as well as participating laboratories; (2) help in developing and reviewing the validation study protocols; and (3) help in reviewing the data resulting from the validation studies and reviewing the manuscript describing the results. These activities will be coordinated by the CSO.

Method Selection Worksheet

Method Title: Method Number: Overall evaluation score (1being lowest, 10 being highest): Additional Factors to Consider:

Recommendation: Signature (date):

Approved by Official Methods Board, November 13, 2008 Approved by AOAC Board of Directors, December 9, 2008 Appeals Process Appended – September 2009 Revisedby AOAC Board of Directors, May 25, 2011

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