Applying QbD to Chromatography for Pharma

The application of Quality by Design (QbD) to chromatographic method development builds quality into products and processes by implementing several principles that include:

  • Systematic design of method space through multivariate parameter optimization
  • Minimizing risk by developing robust methods with automated control
  • Leveraging scientific knowledge to support establishment of the design space

Using a QbD approach in chromatographic method development builds robustness into a reliable method that can be carried forward, eliminating the costs and delays associated with re-developing and re-validating unreliable methods.

ACD/AutoChrom MDS facilitates the application of QbD principles, in a number of ways, to develop efficient and robust chromatographic methods.

Multivariate Parameter Optimization

Traditional trial-and-error based approaches to developing LC methods are time-consuming and difficult, generating large volumes of data. A QbD approach systematically optimizes multivariate parameters by evaluating complex interaction effects between method variables. Experiments that are less likely to yield acceptable results are eliminated in advance, meaning fewer injections and faster method development.

The systematic examination of variables prior to experimentation also allows a larger experimental space to be covered, focusing experimentation on the optimal range for each variable, resulting in better quality methods.

Ensure Method Robustness

Method robustness is modeled through evaluation of the edges of a design space, providing greater understanding of the method parameters that affect the quality of the separation, also supporting the establishment of method design space and providing justification for regulatory approval. Evaluating robustness early in development ensures success in final method validation/transfer and reduces the need for CAPA (Corrective Action Preventative Action) interventions.

Manage Chromatographic Knowledge

Clear and concise project management tools provide an overview of your project, with links to raw data, method parameters, and other relevant user data. Build a knowledgebase of prior experimental data and add new data, as it is acquired. All of the information needed to collaborate, validate, justify, and report is easily accessible.

Greater Efficiency

Faster method development, and better quality methods means greater efficiency and reduced operating costs through solvent saving measures, short run times, and a reduction in manual interpretation. Eliminate duplication and reduce the time spent searching for, and reporting, data manually.

ACD/AutoChrom software for logical method development based on Quality by Design (QbD) principles lets you define the project and your goals at the start of method development, then guides you through data processing, and helps select and carry out the next experiment to quickly develop fast, efficient, high resolution chromatographic separations.