Optimizing Pharmaceutical Production Processes Using Quality by Design Methods

Free Whitepaper

In pharmaceutical manufacturing, it is not enough to simply demonstrate that a particular set of production parameters results in a safe and effective product; it is far more useful to demonstrate the boundaries for each parameter within which quality objectives can be achieved. 

This white paper uses a case study to demonstrate that quality by design goals can be derived in a straightforward way and that this method allows for further improvement of the process without the need for re-registration.

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JMP Capabilities Ideal for Pharmaceutical Process Engineers and Scientists

  • Quality by Design

    Allows pharmaceutical manufacturers to identify and evaluate all sources of variability with respect to quality parameters of the finished product.

  • Statistical Process Control

    Separate common and special causes to assist your process analysis efforts, including problem investigation, out-of-control conditions and ongoing monitoring of stability.

  • Design of Experiments

    Actively manipulate factors according to a pre-specified design to quickly and easily gain useful, new understanding.

  • Dose Response

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  • Product Stability Analysis

    Specialized applications for product stability analysis, PK/PD curve fitting, and 4PL and 5PL models with parallelism for relative potency.

  • Robust Process Optimization

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Ono Pharmaceutical

“With its simple operation method – ‘put in data and results come out’ – JMP is really easy to use. The effect of the contour line profiles (created based on the models) on quality within the manufacturing operation parameters is reflected visually. So creating highly robust processes with JMP is easy.”
-- Tatsushi Murase, Chemical Process R&D Researcher