How measurement uncertainty could strengthen ICH Q14 analytical procedure development

As pharmaceutical analytical procedures become increasingly sophisticated, confidence in the results they generate is more important than ever. In this insightful article for Manufacturing Chemist, Frank Judge, Associate Consultant Chemist at Butterworth Laboratories, examines how integrating measurement uncertainty (MU) into the ICH Q14 analytical procedure development framework could strengthen method development, validation, lifecycle management and regulatory decision-making. By demonstrating how MU provides a quantitative measure of confidence in analytical results, the article highlights its potential to enhance risk-based decision-making, improve regulatory confidence and ultimately support the delivery of safer, higher-quality pharmaceutical products.

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