Stephan Krause, PhD

QbD for QA? Try a two-step approach

The industry needs to open up to validation failures.

It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.

The first part of this article, published in the September 2006 issue, discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.