Fusion QbD Product Development

Designed for the scientist or engineer, Fusion QbD Product Development is quality by design software that facilitates the successful adoption of quality by design (QbD) methodologies by the non-statistician.

Within the pharmaceutical sector there has been a major push by regulators (ICH, FDA, MHRA, etc.) for the adoption of quality by design. At the heart of QbD methodology is Design of Experimentation (DOE), multi-variant analysis, and mathematical modelling. This presents a challenge to the scientific community who are experts in their respective fields (e.g. synthetic, analytical or formulation chemistry), but not trained statisticians. In addition the pharmaceutical environment is very different to that of the mathematician, where GMP and 21 CRF Part11 requirements do not apply. Consequently generic statistical applications such as Design-Expert to name just one, do not conform to these standards.

Fusion QbD Product Development is different. It keeps the user in their comfort zone with an intuitive user interface and automated experiment design wizard which ensures statistically valid designs are used. Testing templates help organise data from complex experiments such as dissolution and cascade impaction studies. This aids the validated data exchange with chromatography data systems with the automatic creation of required sequences. The raw CDS data generated can then imported back to Fusion QbD where advanced data treatment tools are available to process the raw data into modellable terms. A 21 CFR Part 11 compliance toolset completes the “must have” functionality, making Fusion QbD Product Development the ideal quality by design software for oral, parental, topical, and respiratory drug development activities.

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  • Implements Quality by Design methodology into your Product/Process development activities
  • Automated selection of appropriate Experimental Design
  • Eliminates Transcription
  • Reduces Analyst Error
  • Incorporates Risk Assessment metrics into Design Space
  • FDA 21 CFR Part 11 and GMP Compliant Environment

Fusion Product Development provides a simple template for the definition of the Experimental Region, that is the study parameters and their study ranges that will become the Knowledge Space. Based on the types of variables defined Fusion QbD automatically selects the most efficient design suitable for modelling the data, including the higher order models required to visualize the complex interactions effects usually responsible for a lack of Robustness.

Both process and mixture variables are supported, perfect for formulation studies. Split-plot designs are also available to overcome circumstances where there may be restrictions on randomisation.

In the automated mode Fusion QbD ensures Design of Experiments (DOE) best practices are always adhered to with the appropriate number of repeats, centre points, and degrees of freedom. Alternatively the user interactive mode allows a statistician full control over the choice of design and associated design structure settings. These can be templated and then made available for the non-statisticians use. Available design types include:

  • Full and Fractional Factorial
  • Plackett-Burman
  • Box-Behnken
  • Central Composite
  • Star
  • Mixed Level
  • Model-Robust Algorithm (Letter Optimality)

Any study is likely to require data from a range of measurement systems to determine the necessary Critical Quality Attribute results. A tablet formulation study for example may require “basic” hardness testing as well as the more “complex” dissolution testing. Fusion quality by design software allows for all these types of data.

Where there is only one measurement per experiment whose result is to be modelled, the data may be entered directly as “modellable data”. Where more complicated testing is required Testing Plans allow for measurement raw date to be processed into “modellable terms”

Test Plan options include:

  • Descriptive Statistics – Allow the definition of preparation and test repeats
  • Time Series – Allows sampling time points to be defined.
  • Respiratory Toolkit – Allows cascade impaction testing to be defined.

Much of any products development work will involve characterization by chromatography instruments. This is particularly true for pharmaceutical products. Fusion QbD uses a fully validated, GMP compliant, file-less data exchange to integrate with your chromatography data system (CDS). This integration allows the experimental testing plans to be translated into a ready to run sequence(s). Executing the sequences and processing the resultant chromatograms remains the role of your data system.

Chromatogram results are automatically imported from completed sequence(s) in a fully audited process. This ensures each data point is traceable to its source chromatogram within the data system.

Supported CDS:

  • Waters® Empower™ (II & III)
  • Agilent® Chemstation™
  • Agilent® OpenLab (Chemstation Edition)™
  • Thermo® Chromeleon™

Automated data analysis provides a full suite of statistical reports that underpin the models’ adequacy. These include error analysis, residual tables and plots, and pareto ranking reports. Effective visualization of relationships between experimental parameters (critical process parameters) and results (critical quality attributes) is achieved via effects plots, contour plots and response surfaces. These promote knowledge and understanding.

The “Best Answer Search” feature, allows for the study performance goals to be entered and a search of the knowledge space initiated for the conditions/formulation that meet or exceed these goals.

However, no quality by design software is complete without proper consideration of Robustness. Fusion QbD includes the patented Robustness Simulator which allows the calculation of Process Capability metrics (Cp, Cpk, Cpm, and Cpkm) using Monte Carlo Simulation.

This allows for optimisation of the product or process for both mean performance and robustness goals simultaneously.

Graphical tools allow for the visualization and reporting of the multi-dimensional Design Space, within which a Control Space may be defined, verified and reported.

All associated experimental, statistical, and prediction reports are available for collation into a single report to support and defend decision making with sound experimental and statistical evidence. This may be electronically signed and/or exported to various file types as your needs require.

However, no quality by design software is complete without proper consideration of Robustness. Fusion QbD includes the patented Robustness Simulator which allows the calculation of Process Capability metrics (Cp, Cpk, Cpm, and Cpkm) using Monte Carlo Simulation.

This allows for optimisation of the product or process for both mean performance and robustness goals simultaneously.

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