Quality Metrics in Pharmaceuticals – Chance or Challenge? – Get the Expert's Perspective!

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Just to continue the Way

For FDA it is part of the ongoing journey towards a science- and risk-based regulation that also includes GMP regulations, quality management and inspections, just to mention a few. This connection is important because if you understand the aim and direction, the implementation is not only a burden but also a help.

All modern companies, including pharmaceutical, are using indicators such as KPIs for their performance and the effect of business initiatives, including for quality activities. It differs among companies what is measured and how the metrics are managed but all companies above a certain size have implemented them.

How to Meet FDA´s Expectations?

The FDA expectations for Quality Metrics are not different. It is a set of business metrics which is related to the quality performance of a pharmaceutical company and part of the basis for a risk-based approach to inspections. FDA calls it an element of the quality oversight of the pharmaceutical industry.

FDA is emphasizing that data should be objective, subjected to inspection and valuable in assessing the overall state of quality of the product and processes. Furthermore, it should show the commitment of the company and avoid undue reporting burden. They are not intended to be all-inclusive for what is necessary to evaluate a product and the manufacturer’s state of quality.

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