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White Paper: Required and Optional Quality Metrics

The FDA released a Request for Quality Metrics Guidance Draft-document in July of 2015. While the guidance on Quality Metrics is not binding, it is a tool to understand the thinking and direction of the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) on Quality Metrics, and their expectations for continuous improvement.

Quality Metrics are used throughout industry to continually monitor the performance of quality systems and processes.  With a continuous improvement focus, metrics support a quality driven culture.

Access our white paper to view a listing of the required and optional data referenced in the Guidance document.

NOTE: This document is intended to provide a high level overview of the Quality Metrics Guidance Document.  This guide is not intended to replace the FDAs Request for Quality Metrics Guidance document.

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