A Guide to implementing FDA-recommended Quality Metrics in 2022

In recent years, FDA expressed interest in using relevant quality metrics for better planning their risk based inspections. This initiative started off with a Voluntary Phase and subsequently a revised draft guidance was published. Since the advent of this initiative a lot of feedback has been provided by the Industry, particularly its concern of additional efforts and expenses.

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In this White Paper, we will be exploring what these Quality Metrics are, and how can one implement them. The contents of this White Paper include:

• List & definitions of FDA-recommended Quality Metrics
• Step by step methodoloy of implementing Quality Metrics
• Example calculations of the following key Quality Metrics