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International coordination and validation of analytical methods

W Horwitz1

  • 1Food and Drug Administration, Washington, DC 20204.

Food Additives and Contaminants
|January 1, 1993
PubMed
Summary
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Collaborative interlaboratory studies are essential for validating analytical methods across diverse labs. A 1987 protocol standardized data interpretation for reliable method variability assessment.

Area of Science:

  • Analytical Chemistry
  • Laboratory Science
  • Method Validation

Background:

  • Traditionally, analytical method experimentation occurred within single laboratories.
  • Interlaboratory validation was historically avoided due to perceived result variability.

Purpose of the Study:

  • To establish a standardized protocol for designing and interpreting data from collaborative analytical method studies.
  • To address the growing need for interlaboratory validation driven by international standards.

Main Methods:

  • Development and consensus approval of a protocol for collaborative studies.
  • Focus on estimating variability characteristics of analytical methods across typical laboratory populations.

Main Results:

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  • A consensus protocol was approved by international organizations in Geneva, May 1987.
  • The protocol provides a common basis for measuring statistical characteristics of analytical methods.

Conclusions:

  • Collaborative interlaboratory studies are now recognized as crucial for method validation.
  • Standardized protocols ensure reliable assessment of analytical method performance and variability.