The Metrics of Quality Culture

Harrison, Andrew; Schniepp, Susan
September 2015
Pharmaceutical Technology;Sep2015, Vol. 39 Issue 9, p22
Trade Publication
The article discusses the guidance for quality metrics proposed by the U.S Food & Drug Administration (USFDA). Topics discussed include passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) to prevent drug shortage, use of the guidance by pharmaceutical industries to internally measure performance and factors such as manufacturing site performance and quality-system metrics that should be evaluated when establishing a metrics program.


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