AOAC INTERNATIONAL Official Methodssm Program

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AOAC INTERNATIONAL Official Methodssm Program

• E. Olayinka Ladeji
• Program Manager, Method Validation
• AOAC INTERNATIONAL
• September 11, 2005OMB Training Workshop
• 119th AOAC Annual Meeting and Exposition

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AOAC Official Methodssm - Who?

• Study Director
• General Referee
• Recognized experts in the field of study
• Methods Committees - 11
• Experienced scientists
• Statisticians, safety advisors
• Official Methods Board
• Method committee chairs

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AOAC - Study Director

• Recognized experts in the field of study
• Develops and validates method for study
• Prepares protocols
• Conducts the collaborative study
• Prepares the study manuscript

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AOAC - General Referee

• Recognized experts in the study topic
• Experience with collaborative studies
• Mentor to the Study Director
• Reviews and approves study protocols and reports

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AOAC - Method Committee

• Recognized experts in the field of study
• Experience as Study Director and General Referee
• Review and approve study protocols and reports
• Approve methods for AOAC Official First Action

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AOAC Official Methods Board

• Methods Committee Chairs
• Safety and Statistics Committee Chairs
• 2 Members review collaborative study manuscripts
• Vote on Final Action
• Recommend policy changes to AOAC Board of
  Directors

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Step 1 - Method Development

• Non-AOAC function
• Independent laboratory
• Industry
• Government
• Academia
• Contract laboratory
• Method selected

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Step 2 - In-House Method Validation

• Performance parameters
• Precision
• Accuracy
• Ruggedness
• Linearity
• Limit of detection
• Comparison to other methods
• Acceptable method performance

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Microbiology Method Validation

• Precollaborative study
• Methods comparison of alternative method against
  reference method
• Counterpart to SLV for chemistry methods
• Collaborative study
• Study of reproducibility

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Step 3 - Method Submitted to AOAC

• Method of analysis
• Detailed procedure
• In-house validation data
• Demonstrated performance
• Study Director appointed
• Collaborative study protocol
• Detailed study design

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Step 4 - Protocol Review by AOAC

• Safety advisor
• Statistician
• Adequate sample analysis
• General Referee
• Scientific review
• Method Committee
• Official Methods Board

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Step 5 - Method Collaborative Study

• 8 - 10 laboratories minimum
• Minimum of 8 labs with acceptable data (chemistry
  and quantitative microbiology)
• Minimum of 10 labs (qualitative microbiology)
• 5 samples or test materials (chemistry)
• Materials must cover the range of assay
  applicability
• Blind duplicates
• SRM or Control Material

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Step 6 - Collaborative Study Report

• Detailed final method
• Study report
• Comments from laboratories
• Statistical analysis
• Critical performance evaluation
• Recommendations

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Step 7 - Collaborative Study Report Review by
AOAC

• Safety Advisor
• Statistician
• All AOAC requirements met
• General Referee
• Scientific evaluation
• Method Committee
• Scientific evaluation
• Official Methods Board

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Step 8 - Official Methodsm Approval

• Method Committee
• Official First Action method
• Method published in OMA
• Collaborative study published in JAOAC
• Official Methods Board
• Final Action method

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AOAC Method Validation Process
Author submits collaborative study protocol
AOAC appoints Study Director (SD)
Collaborative study protocol reviewed by general
referee, statistician, safety advisor, 3
committee members. Comments forwarded to SD
Revision Requested
Protocol revised and submitted
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AOAC Method Validation Process (cont)
Revision Requested
Methods committee report sent to SD
Protocol revised and submitted
Conduct collaborative study
SD submits collaborative study manuscript
AOAC forwards collaborative study manuscript
reviewed by general referee, statistician, and
safety advisor for review
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AOAC Method Validation Process (cont)
Revision Requested
Comments sent to SD
Manuscript revised and submitted
Collaborative study manuscript sent to methods
committee and 2 OMB members for review
Revision Requested
Reviewer comments sent to chair for
summarizing. Summary sent to SD
Rejected
Manuscript revised and submitted
SD requests appeal to OMB
Method approved as first action by the methods
committee
Method published in OMA
Collaborative study published in JAOAC
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AOAC Official Methodssm - Summary

• Gold Standard methods
• Universal acceptance
• Demonstrated performance
• Harmonized protocols
• Guidebooks and assistance
• Validation experience