Pharmaceutical manufacturers are starting to find the process-capability holy grail of six sigma – a goal that many thought not long ago was unattainable for pharma.
In applying the Deming principles of variability reduction and organizational understanding, manufacturers are reporting substantial decreases in waste, process deviations, and inventory that translate into several hundred million dollars in savings.
The progress pharma is making down the six sigma pathway, and the quality tools supporting that progress, were explored at the FDA/PQRI conference on “Advancing Product Quality,” cosponsored by the agency and the Product Quality Research Institute (PQRI) in October in Bethesda, Maryland.
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