Analytical Quality by Design (AQbD) in practice: the question nobody asks out loud
There is a question that comes up regularly in analytical development, in project meetings, in scientific reviews or in conversations with clients but that rarely gets asked directly, and almost never makes it into formal documentation:
"Are we doing too much?"
Not because we are looking for shortcuts. But in the sense of: is this level of investigation actually proportionate to the decision we need to make?
Since the publication of ICH Q14, AQbD is no longer optional. The framework is clear, the expectations are set. But the guidance says almost nothing about how to calibrate the depth of application to the actual context of a project.
Within laboratory teams, this creates a recurring tension. Additional studies may strengthen confidence in a method, but they can also extend timelines, increase complexity and generate information that does little to support your next decision.
The industry is starting to measure this
This dilemma is not specific to any one organisation. The French Society of Pharmaceutical Sciences and Techniques (SFSTP) has launched a barometer specifically designed to capture how organisations are actually implementing AQbD in practice in the industry.
If you work in analytical development, method development, QA or regulatory affairs, your input matters to capture where the industry really stands.
Our perspective on the question
At Quality Assistance, this question is one we navigate daily, and it inspired our first Analytical Perspective.
Rather than explaining AQbD one more time, we explore the practical challenge behind it: how do you determine the right level of analytical effort for each project and what is the most common misconception that leads teams to get this wrong?
It doesn't offer a formula, or a complete overview of the subject. What it offers is a way of thinking about the problem.
Analytical Perspective - The biggest misconception about AQbD
A practical framework for deciding how much analytical effort each project needs, and the misconception that leads teams to overdo it.
