Tuesday, June 25, 2013

FDA Considers New Quality Metrics

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System | IPQ Newsletter:

"Based on its review of all the responses submitted on the metrics issue, FDA has chosen three that it is considering using and is seeking additional feedback on:
  • batch failure rate
  • right first time, and
  • out-of-specification (OOS)/laboratory failure investigation rates"
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