In preparation for Stage 1, define an analytical target profile (ATP), show how your method’s performance characteristics meet required criteria, and consider overall measurement uncertainties. Getting in-depth knowledge of what affects your method’s performance using Quality by Design (QbD) concepts helps you ensure your method’s robustness from the start.
The Stages of Method Lifecycle Management
Methods with greater agility, robustness, and capacity for change can help reduce regulatory burden, failure risk, and costs. Discover the stages, concepts, and terms that define lifecycle management, then explore them in depth below.
Design & Development in Depth
Paula Hong of Waters illustrates how the ACQUITY QDa mass detector can be used as an orthogonal detection approach to UV in methods development.
The ACQUITY QDa mass detector aids in efficient and robust method development, minimizing the need for standards to confirm peak identity by retention time. In this video, we demonstrate the use of qualitative mass spectral data in method development, using an ACQUITY QDa mass detector to confirm the identity of ziprasidone HCl and related compounds.
Reducing sources of variability is key to the MLCM process. Empower scoring reports allow users to choose the best conditions for their methods, relying on metrics instead of individual judgement. The scoring report allows the user to quickly identify the conditions that met the pre-established criteria (ATP) — removing analyst variability and bias in the method development process. This technology brief demonstrates the capabilities of Empower 3 Software for scoring chromatographic separations using custom calculations and custom reports.
This white paper describes a synergistic, systematic, and streamlined approach to method development that takes advantage of UPLC instrumentation, sub-2-μm column chemistries, and Empower 3 Software.
In the following study, a careful evaluation of the USP assay for atorvastatin was performed. To minimize the impact of environmental conditions, both sample preparation and mobile phase composition were controlled using approaches allowed within USP chapter 621. These studies enabled scientists to devise a strategy to minimize any variation in the method transfer of the USP method across multiple labs on different continents.
This application describes a case study where a Quality by Design (QbD) approach was used to develop an analytical stability-indicating method for monitoring degradation of amoxicillin powder for oral suspension. It illustrates how QbD leveraged the software assistance of Fusion QbD to select factor value combinations, create acquisition methods, and evaluate modeled responses.