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Related Experiment Video

Updated: Jun 18, 2026

Applicability Analysis of Assessment Methods for Morphological Parameters of Corroded Steel Bars

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Acceptance criteria for method equivalency assessments.

Marion J Chatfield¹, Phil J Borman

¹GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK. marion.j.chatfield@gsk.com

Analytical Chemistry

|November 21, 2009

Summary

This summary is machine-generated.

Setting acceptance criteria for method equivalence is crucial for quality by design (ICH-Topic Q8). This involves understanding patient and producer risks for meaningful assessments.

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Area of Science:

Pharmaceutical Science
Analytical Chemistry
Quality Control

Background:

Quality by Design (ICH-Topic Q8) mandates robust process control strategies.
Method equivalence assessments are vital for managing changes to analytical methods throughout a product's lifecycle.
Establishing appropriate acceptance criteria is a critical, yet often unclear, prerequisite for these assessments.

Purpose of the Study:

To discuss various approaches for setting acceptance criteria for method equivalence.
To provide detailed methods for setting acceptance criteria based on patient and producer risk.
To illustrate the application of these criteria to drug substance assay methods.

Main Methods:

Literature review of proposed approaches for setting acceptance criteria.
Discussion of criteria based on patient and producer risk, including tolerance intervals and method/process capability.
Application to a drug substance assay method for batch release.

Main Results:

The assessment of method equivalence requires a clear understanding of method control requirements.
Different approaches to setting acceptance criteria serve different purposes.
Analyst judgment is essential in determining appropriate acceptance criteria, rather than relying on a single algorithm.

Conclusions:

Meaningful method equivalence assessments depend on a thorough appraisal of method control requirements.
Setting acceptance criteria involves balancing patient and producer risks.
Expert judgment plays a key role in defining acceptance criteria for method changes.