Micro Article - Jan 2020

A Guide to implementing Quality Metrics in 2020 [Part 1 of 2]

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 This initiative started off with a Voluntary Phase and subsequently a revised draft guidance was published in 2016. Since the advent of this initiative a lot of feedback has been provided by the Industry, particularly its concern of additional efforts and expenses.

In this Micro Article (Part 1 of 2), we will be exploring what these Quality Metrics are, and how can one implement them.

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