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Developing a design space for OTC manufacturing

Developing a design space for OTC manufacturing

In this application note, we explain how comprehensive, process relevant characterization of wet granules can lead to control of tablet CQAs and assist Design Space definition in the manufacture of an OTC medicine.

The adoption of a Quality by Design (QbD) approach to wet granulation requires manufacturers to fully understand the relationship between process variables, such as powder properties and equipment settings, and Critical Quality Attributes (CQA) of the resulting product. Manufacturers need to develop a Design Space by understanding the impact that variations within the process have on the properties of the resulting granulate and the influence they, in turn, have on final product quality. Furthermore, a robust Design Space allows process variables to be controlled and manipulated to produce quality assured tablets with targeted properties.