Guest Column
Quality By Design: Learning From Experience
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•Guest Column: Quality By Design: Learning From Experience
By Tim Freeman, Freeman Technology
While adopting Quality by Design opens the way to increased operational flexibility and efficiency, its achievement requires the pharmaceutical industry to extend its knowledge base, especially in key areas such as powder processing. Within the industry, manufacturing success is usually assured by adhering to detailed procedures, having a formulation that works, rigorously testing in-process material, and perhaps most crucially, drawing on operating expertise developed over the years, tricks that ease the processing of difficult batches. Such expertise is hard won, and valuable, but tends to be very limited in its applicability. One cost-effective way of accessing the information required for QbD is to unlock the knowledge inherent in experience, using modern powder characterization techniques.
Experience of a specific unit operation — a blender, tablet press, or granulator, for example — often exists simply in the form of formulation A processes easily; formulation B is OK if we modify x, y, and z; and formulation C won't process at all. Relating this to the properties of the three powders gives important insight into the links between process behavior and material characteristics. Many conventional powder testers describe a powder using only a single variable, but modern systems, such as the FT4 from Freeman Technology, provide multivariate characterization, making it easier to identify the important parameters. Dynamic, bulk, and shear powder properties in combination provide the fullest description of the powder.
Click Here To Download:•Guest Column: Quality By Design: Learning From Experience
