A Continuous Improvement Metric for Pharmaceutical Manufacturing: Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

PHARMACEUTICAL industry; UNITED States. Food & Drug Administration; EUROPEAN Medicines Agency; WORLD Health Organization; GOVERNMENT agencies

The article discusses a draft guidance by the Food and Drug Administration (FDA) which focuses on the importance of continuous improvement in the pharmaceutical industry by eliminating wasted effort, optimizing processes and reducing variability. According to the author, process verification as outlined in the regulatory guidance established by regulatory agencies like World Health Organization (WHO), the European Medicines Agency (EMA) and FDA helps prevent product failures.