Information about method requirements is itemized into nine categories: (1) intended use; (2) applicability; (3) analytical technique; (4) definitions; (5) method performance requirements; (6) system suitability; (7) reference materials; (8) validation guidance; and …

When a method is verified, the laboratory is required to demonstrate that it can achieve certain specific performance characteristics/parameters established during the validation study. The validation study must contain all pertinent performance characteristics.

This course is a one-day review of the technical validation requirements and processes of the Performance Tested Methods ℠ and Official Methods of AnalysisSM programs.

1.1.1 Validation is the process of demonstrating or confirming the performance characteristics of a method of analysis. This process of validation is separate from the question of acceptability or the magnitude of the limits of the characteristics examined, which are determined by the purpose of the application. Validation applies to a

This document provides guidelines for the AOAC validation of microbiological methods for food and environmental surfaces.

During early stages of method development, the robustness of methods should be evaluated 106 because this characteristic can help you decide which method you will submit for approval.

All media recommended for use with the candidate method must be validated. Test one replicate per strain per medium using the candidate method. AOAC OFFICIAL METHODS OF ANALYSIS (2012) Inclusivity and exclusivity evaluations shall be performed together as one study.

Validation, Traceability and MU BAM, May 2012 3 Background for the Codex Alimentarius’ method criteria Advantages with criteria” approach : greater flexibility In some areas of food analysis there are many methods of analysis which are available, which meet Codex requirements as regards method

AOAC INTERNATIONAL brings together government, industry, and academia to establish standard methods of analysis that ensure the safety and integrity of foods and other products that impact public health around the world.

Method validation data submitted should address the following issues: - Linearity of response for the analyte (and internal standard, if appropriate), in the method.