Quality Metrics: What Gets Measured, Gets Done

white-paperNSF Health Sciences
April 9th 2015

ABSTRACT

The push for quality metrics took a major step forward in July 2012, when the US Food and Drug Administration Safety and Innovation Act (FDASIA) was passed. To comply with Good Manufacturing Practices (GMP) pharmaceutical companies should establish performance indicators to monitor the effectiveness of the pharmaceutical quality system and include processes such as corrective and preventive action (CAPA), deviations, complaints, audits and regulatory inspections.

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