One focus of the regulations implemented by the U.S. Food and Drug Administration (FDA) during the past several years has been on quality in batch-to-batch production in the pharmaceutical industry. Batch quality not only ensures safe product for consumers, it also has the added benefit of saving pharma companies money. It’s a waste of time and money to go through the long process of manufacturing a large batch of a drug, only to throw it away on final inspection.

The FDA’s Process Analytical Tools (PAT) regulations offer guidelines on how to incorporate quality throughout the manufacturing process of pharmaceuticals. In a recent Minitab case study, Catalent Pharma Solutions demonstrated how Minitab Statistical Software was used to reduce batch-to-batch variability and avoid lost batches, saving thousands of dollars.

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