SANTE Document 11312/2021: Quality Control and Method Validation for Pesticide Analysis

SANTE Document 11312/2021: Quality Control and Method Validation for Pesticide Analysis

330,00 €

This document is intended for laboratories participating in Pesticide Residue Analysis in Food and Feed throughout the EU. We will clarify the aspects included in the 2021 revision regarding operational requirements, method validation, and quality control, aiming to provide confidence in the data generated and reported within the framework of official pesticide residue controls. This revision of SANTE Document 11312/2021 includes some updates on topics such as result calculation with correction factors, rounding of results, SRM uncertainty, and the definition and clarification of terms.

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  1. INTRODUCTION AND LEGAL BACKGROUND
  2. SAMPLING, TRANSPORT, TRACEABILITY, AND STORAGE OF SAMPLES
  3. SAMPLE ANALYSIS
    • Sample preparation and processing
    • Extraction
    • Cleanup, concentration/reconstitution, and storage of extracts
    • Determination and chromatographic separation
    • Calibration
    • Quality assurance: quantitative methods
    • Screening methods
    • Interlaboratory comparison exercises
  4. ANALYTE IDENTIFICATION AND RESULT CONFIRMATION
  5. REPORTING OF RESULTS
  6. PESTICIDE STANDARDS, STANDARD SOLUTIONS, AND CALIBRATION STANDARD SOLUTIONS
  7. ANALYTICAL METHOD VALIDATION AND PERFORMANCE CRITERIA
    • Quantitative methods
    • Screening methods
  1. INTRODUCTION AND LEGAL BACKGROUND
  2. SAMPLING, TRANSPORT, TRACEABILITY, AND STORAGE OF LABORATORY SAMPLES
    1. Sampling
    2. Transport
    3. Traceability
    4. Storage
  3. SAMPLE ANALYSIS
    1. Sample processing and preparation
    2. Extraction
    3. Cleanup, concentration/reconstitution, and storage of extracts
  4. CHROMATOGRAPHIC SEPARATION AND DETERMINATION
  5. CALIBRATION
    1. Introduction
    2. Calibration with matrix-matched extract (MATRIX-MATCHED CALIBRATION)
    3. Calibration with standard additions
    4. Calibration with extracted blank sample (PROCEDURAL STANDARD CALIBRATION)
    5. Calibration of pesticides that are mixtures of isomers
    6. Use of internal standards
    7. Data processing
  6. PESTICIDE STANDARDS, INTERMEDIATE (STOCK) SOLUTIONS, AND CALIBRATION STANDARD SOLUTIONS
    1. Identity, purity, and storage of reference standards (pure)
    2. Preparation and storage of standard solutions (stock or intermediate)
    3. Checking and replacement of standards
  7. ANALYTE IDENTIFICATION AND RESULT CONFIRMATION
    1. Identification
    2. Result confirmation
  8. ANALYTICAL METHOD VALIDATION AND PERFORMANCE CRITERIA
    1. Quantitative methods
    2. Screening methods
  9. QUALITY CONTROL
    1. Quantitative methods
    2. Screening methods
    3. Trend evaluation
    4. Interlaboratory comparison exercises
  10. REPORTING OF RESULTS
    1. Expression of results
    2. Calculation of results
    3. Bias correction
    4. Rounding of results
    5. Result grading with measurement uncertainty
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