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QbD 'Designed In' to Dry Granulation

16th Mar 2011

Process Analytical Technology (PAT) enabled Continuous Granulation

The industry is steeped in a history of batch based manufacturing unlike other sectors such as food and bulk chemicals. This is to give the accountability and traceability required to ensure drug safety to the public. After several years of focus on establishing new ways of analysing drug variability and quality in the various manufacturing process stages, under the Process Analytical Technology (PAT) initiative, the industry is now able to move to advanced techniques to analyse consistency on a time based approach (RTR) rather than conventional batch sampling and analysis. The challenge is now for the industry to take this QbD concept and look at its manufacturing processes in ‘lean’ terms to start to adapt for a more efficient future.

Some existing process technologies are ideally suited to the new era of solid dose pharmaceutical efficiency.

Read technical paper: QbD 'Designed In' to Dry Granulation