INTERNATIONAL STAKEHOLDER PANEL ON ALTERNATIVE METHODS (ISPAM)

INTERNATIONAL STAKEHOLDER PANEL ON ALTERNATIVE METHODS (ISPAM)

ISPAM Purpose

AOAC Standards & Stakeholder Panels

ISPAM AGENDAS

• Working Groups Agenda June 29-30 Mid-Year Stakeholder Mtg.

• ISPAM Agenda September 16, 2011 New Orleans, LA
  
  
  

1.  Advisory Panel

• Minutes

  • Minutes Advisory Panel Sept. 28, 2011

  • Minutes Advisory Panel March 15, 2011

  • Minutes Advisory Panel April 12, 2011

  • Minutes Advisory Panel April 21, 2011

  • Minutes Advisory Panel April 22, 2011
    
    
    

2.  Working Group on MICROBIOLOGICAL GUIDELINES

• Minutes

  • Minutes Microbiological Working Group April 27, 2011

  • Minutes Microbiological Working Group May 06, 2011

  • Minutes Microbiological Working Group May 27, 2011

  • Minutes Microbiological Working Group June 30, 2011

  • Minutes Microbiological Working Group Sub-Group August 16-17th, 2011
    
    
    

• Documents:

  • Guidance Document for Sampling and Lotting of Beef Products and Sample Analysis for Pathogens - Developed by the Beef Industry Food Safety Council
    
    

  • 2.1 Comparison Chart Micro Methods 6-2-11v3
    
    

  • 2.2 AOAC INTERNATIONAL Presidential Task Force on Best Practices for Microbiological Methodology (BPMM) 
    
    

  • 2.3 Alternative Microbial methods: An overview & selection criteria, by Vicky Jasson,Liesbeth, Jacxsens, Pieternael lLuning, Adreja Rajkovic, Mieke Uyttendaele Food Microbiology 27, (2010) 710-e730) 
    
    

  • 2.4 Estimation of the POD Function and the LOD of the Qualitative Microbiological Measurement Method, Cordula Wilrich, Peter-Theodor Wilrich, Journal of AOAC International Vol.92, No. 6
    
    

  • 2.5 Health Canada Part 4 Annex 

    • 2.5.1 Health Canada Part 4 Annex 4.1 E
      

    • 2.5.2 Health Canada Part 4 Annex 4.2 E
      

    • 2.5.3 Health Canada Part 4 Annex 4.3 E
      

    • 2.5.4 Health Canada Part 4 Validation of a Qualitative Method E final 
      
      

  • 2.6 Probability of Detection (POD) as a Statistical Model for the Validation of Qualitative Methods, Paul Wehling, Robert A. 
    LaBudde, Sharon L. Brunelle, Maria T. Nelson, Journal of AOAC INTERNATIONAL Vol. 94, No. 1, 2011
    
    

  • 2.7 Committee Draft on part 2 of prISO 16140 “Microbiology of food and animal feeding stuffs – Method validation” ISO/TC34/SC9 N 1199 2011-04-06
    
    

  • FSIS Guidance for Test Kit Manufacturers, Laboratories: Evaluating the Performance of Pathogen Test Kit Methods
    
    
    

3.  Working Group on QUALITATIVE CHEMISTRY GUIDELINES

• Minutes:

  • Minutes Chemistry Working Group September 16, 2011

  • Minutes Chemistry Working Group April 27, 2011

  • Minutes Chemistry Working Group May 31, 2011

  • Minutes Chemistry Working Group June 30, 2011
    
    
    

• Documents:

  • 3.1 A Protocol for the Validation of Qualitative Methods of Analysis – DRAFT Roy Macarthur, Christoph von Holst
    

    • Draft Protocol for the Validation of Qualitative Methods
      
      

    • Draft Protocol Validation Figures and tables
      
      

  • 3.2 Validation Scheme for Qualitative Analytical Methods, ISO Technical Committee 34, Standing Committee 16, Horizontal 
    Methods for molecular biomarker analysis, 2011
    
    

  • 3.3 Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis (IUPAC Technical Report), Pure Apppl. 
    Chem.,Vol. 74, No. 5, pp 835-855, 2002
    
    

  • 3.4 AOAC Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals, AOAC® OFFICAL METHODSsm PROGRAM MANUAL (OMA Program Manual), AOAC INTERNATIONAL, Dec. 19, 2002
    
    

  • 3.5 Standard Format and Guidance for AOAC Standard Method Performance Requirement (SMPR) Documents (Version 12.1; 31-Jan-11) DRAFT
    
    

  • 3.6 Expert Review Panel Guidelines for Validation of Botanical Identification Methods, DRAFT, AOAC INTERNATIONAL 2011
    
    

  • 3.7 Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA 
    Sequences and Specific Proteins in Foods, Codex Alimentarius Commission Manual, CAC/GL 74-2010
    
    

  • 3.8 Probability of Detection (POD) as a Statistical Model for the Validation of Qualitative Methods, Paul Wehling, Robert A. 
    LaBudde, Sharon L. Brunelle, Maria T. Nelson, Journal of AOAC INTERNATIONAL Vol. 94, No. 1, 2011
    
    

  • 3.9 Guide in Validation of Alternative Proprietary Chemical Methods, NordVal Validation, NordVal Protocol No. 2, Approved 26, May 2010
    
    

  • 3.10 AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Biological Trheat Agent Methods and/or Procedures (BTAM), Journal of AOAC INTERNATIONAL Vol. 94, No. 4, 2011
    
    

  • 3.11 Presentations: Chemistry Working Group June 30, 2011:
    

    • 3.11.1 Draft AOAC Single Laboratory Validation of the Identification of [botanical or specific botanical material] – Jim Harnley, USDA-ARS BHNRC
      
      

    • 3.11.2 Draft “Protocol for the validation of Qualitative methods of Detection.” (Joint IUPAC/MoniQA protocol for validation of qualitative methods), Monitoring and Quality Assurance (MoniQA), 2011 MoniQA – Roy Macarthur, Food & Environmental Research Agency, UK
      
      

    • 3.11.3 "Validation Scheme for Qualitative Analytical Method." ISO Technical Committee 34, Standing Committee 16, Horizontal methods for molecular biomarker analysis, 2011, and “Probability of Detection (POD) as a Statistical Model for the Validation of Qualitative Methods, JAOAC (95) 335- Paul Wehling, General Mills
      
      

    • 3.11.4 Draft Standard Format and Guidance for AOAC Standard Method Performance Requirement (SMPR) Documents – Scott Coates, Chief Scientific Officer, AOAC
      
      

    • 3.11.5 AOAC INTERNATIONAL Guidelines for Validation of Biological Treat Agent Methods and/or Procedures, JAOAC, (94) – Scott Coates, Chief Scientific Officer, AOAC
      
      

    • 3.11.6 Guide in Validation of Alternative Proprietary Chemical Methods, NordVal Protocol No. 2, Approved 26 May, 2010 – Deborah McKenzie, Sr. Director, AOAC Methods Development and Approval Processes
      
      

    • 3.11.7 Comparison of Current Qualitative Chemistry Method Validation Guidance –Scott Coates, Chief Scientific Officer, AOAC
      
      

    • 3.11.8 Definition of Qualitative Chemistry Methods – Bert Pöpping, Eurofins
      
      
      

4.  Working Group on Statistics

• Minutes:

  • 4.1 Statistic Working Group Initiatives for ISPAM, April 29, 2001
    

  • 4.2 Statistic Working Group ISPAM Minutes, June 29, 2011
    
    
    

5.  ISPAM Joint Session of the Working Groups (June 30, 2011)

Members of the Statistical Working group elaborated and discussed statistical models, concepts, and differences and similarities between Qualitative Chemistry Guideline and the Microbiological Guideline computations.

• Presentations

  • 5.1 Chi Square and the McNemar Model – Dan Tholen, Consultant, and ILAC Liaison to ISO TC69
    

  • 5.2 POD Concept – Paul Wehling, General Mills
    

  • 5.3 LOD and RLOD Models – Robert LaBudde. Least Cost Formulation and Old Dominion University
    

  • 5.4 Review of Statistical Working Group Purpose – Paul Wehling, General Mills

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