Practical Guide to Implementing Analytical Quality by Design (AQbD)
How do you translate ICH Q14, ICH Q2(R2) and USP <1220> into a practical workflow that works in daily analytical development? We have condensed our approach into a clear and digestible summary, illustrated with a real implementation case study.
In this summary, we walk through the complete AQbD workflow step by step: from the method request and the Analytical Target Profile (ATP), through technologies selection, criticality assessment of method parameters, risk management and method development with Design of Experiments (DoE), to the analytical control strategy, implementation, method performance and procedure life cycle management.
The case study shows how we applied this workflow to develop a capillary electrophoresis method for rapid adenovirus quantification in vaccine manufacturing. The result: a method that delivered over 18,000 samples with only 0.6% invalid runs in three years of routine use, and reduced the time-to-result from three days to one hour.
What you will learn from this summary:
- A structured, nine-step AQbD workflow from concept to control
- How to define an Analytical Target Profile that captures analytical and business requirements
- A practical tool to reduce 60+ method parameters to the critical few
- How Design of Experiments reveals interactions and the true optimal conditions
- Three ways to bring every critical method parameter into control: define it, describe it, control it
Download the free AQbD summary here.
Want to learn how to apply this workflow yourself? Join our 2-day AQbD courses in the Netherlands.
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