Article: Analytical Quality by Design (AQBD) approach to support analytics optimisation strategy

Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.

In this article, we discuss the application of QbD to analytical method development ahead of the new ICH Q14 guideline, whose goal is to harmonize the scientific approaches of Analytical Procedure Development. This proposed new guideline aims to improve regulatory communication between industry and regulators, and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.