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Analytical difficulties facing today's regulatory laboratories: issues in method validation.

James D MacNeil¹

¹Department of Chemistry, St Mary's University, Halifax, NS, Canada. jdm4533@eastlink.ca

Drug Testing and Analysis

|August 2, 2012

Summary

Analytical laboratories face evolving challenges in method validation. A strategic approach is crucial for managing changes to ensure methods remain fit for purpose, especially in food import/export testing.

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Area of Science:

Analytical Chemistry
Laboratory Management
Food Safety Testing

Background:

Analytical laboratories continually face challenges in expertise, equipment, and method implementation.
Increased complexity and rapid change necessitate robust management strategies.
International guidelines for food import/export testing integrate quality assurance and accreditation.

Purpose of the Study:

To provide a strategic framework for method validation decisions in analytical laboratories.
To address the complexities of re-validating modified or new analytical methods.
To align laboratory practices with international guidance and regulatory requirements.

Main Methods:

Review of international guidance documents and regulatory requirements.
Analysis of laboratory quality system requirements.
Discussion of typical method change scenarios and validation strategies.
Proposal of a decision process for selecting validation measures.

Main Results:

Method validation is essential to demonstrate a method is 'fit for purpose'.
Changes affecting method scope or performance parameters necessitate re-validation.
A strategic approach is needed to determine the extent of re-validation required for method modifications.
Validation typically encompasses scope, calibration, precision, and recovery.

Conclusions:

A well-considered strategy, informed by current guidance and quality systems, is vital for method validation.
Decisions on re-validation must assess the impact of method changes on performance characteristics.
The proposed decision process aids in selecting appropriate validation measures for modified analytical methods.