The application of Quality by Design (QbD) has become second nature to the pharmaceutical industry. The resulting benefits prompt the question of whether QbD principles are applicable to other processes and analytical method development is now a focus. Just like conventional QbD, analytical QbD (AQbD) holds out the prize of flexibility, in contrast to the rigidity of Standard Operating Procedures (SOPs).
This whitepaper introduces AQbD and examines how the process of developing and validating analytical methods can benefit from the systematic and scientific approach that QbD promotes.
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