AOAC Method Validation Program OMBs Role

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AOAC Method Validation ProgramOMBs Role

• Orlando, Florida
• September 10, 2005

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Need for Review

• Changing demographics
• Changing business model

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What is the problem?

• Critical need for validated methods
• Criticisms of current programs
• Difficulty in knowing what is required
• Information available is confusing,
  misinterpreted
• Too time consuming

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What AOAC proposes

• Revise web site
• Combine the 3 programs into one
• Add missing components

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Missing components

• Advice on sample acquisition
• Advice on reference standards
• Generic protocols for SLV and MLV
• Best practices--recovery and precision
• Examples of acceptable protocols
• Examples of acceptable study reports
• Acceptance criteria

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Missing Components

• Discussion of proper use of HORRAT
• Discussion on method extension (to new matrix or
  analyte)
• Discussion of confirmation of analyte
  identification

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What is Needed

• Clarityeasily understood
• Consistency (esp. terminology)
• Seamless (SLVPVMOM)
• Complete
• Located in one spot
• Easily accessible

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AOAC Method Validation Procedure

• Phase 1 Method Development
• Phase 2 Single Lab Validation
• Phase 3 Multi-Lab Validation

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Method Development Phase

• Determination of purpose and scope
• Selectivity
• Calibration
• Confirmation of analyte identity
• Method optimization
• Ruggedness testing/critical control points
• Method description write-up

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SLV

• Preparation of study protocol
• Develop performance characteristics
• Analyte stability
• Reference standards
• Calculation of within-lab/intermediate precision
• Preparation of study report

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MLV

• Preparation of study protocol
• Invite participation
• Preparation of materials for study
• Homogeneity testing
• Sending test samples
• Obligations of collaborators
• Calculation of reproducibility

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MLV (Contd.)

• Calculation of HorRat
• Preparation of study report with recommendations

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Suggested Addendums

• Definition of Terms
• Writing Method Description
• Generic ProtocolsSLV/MLV
• Examples of Acceptable Protocols
• Acceptance CriteriaSLV/MLV
• Examples of Acceptable Study Reports
• Use of the HorRat
• Statistical Methods
• Peer Review Process
• Acceptance Criteria

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What do you conclude?
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OMB Task

• Streamline
• Clarify
• Seamless
• Complete
• Locate in one, easily accessible spot on web

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Advice

• Review the sections assigned to you with a
  jaundiced eye.
• Ask yourself, What would I like to see on the
  web sight if you were new to method validation?
• Get input from other qualified AOAC members.

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Recommended Reading

• AOAC Requirements for SLV
• PVM Program Manual
• Appendix D of the AOAC Official Methods Program
  Manual
• Harmonized protocol JAOAC Int. 78 (5), 143A-160A
  (1995)
• Method Validation in Pharmaceutical Analysis,
  J.Ermer and J. Miller, Wiley (2000)