Gert Moelgaard about Trends in Pharmaceutical Industry Quality Metrics in Pharmaceuticals – Chance or Challenge? – Get the Expert's Perspective!

Author / Editor: Gert Moelgaard* / Anke Geipel-Kern

Quality Metrics in pharmaceutical manufacturing: challenge or opportunity? A new way of measuring quality performance and quality culture in pharmaceutical companies is on the horizon. Are European companies ready for FDA´s Quality Metrics concept?

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(Picture: NNE Pharmaplan)

The new FDA concept called Quality Metrics is about to become a reality for all companies supplying products to the US market. Some companies have not been aware of the importance of the new concept and have not started to prepare for its implementation.

At first, it may look like a significant challenge, but it is at the same time a significant opportunity if implemented wisely.

Understanding the Background is Important

If you understand the background, it makes a lot of sense and it holds the potential to be a win-win between regulators and industry, but there is still a lot of work to do — and a risk that the concept of Quality Metrics may not deliver to promise.

FDA issued a draft guidance on Quality Metrics in July 2015 and a number of companies have already been through one or two waves of pilot programs that should give industry and FDA the first feedback on how it works and how it could be implemented.