Quality by Design: How to Harvest the Benefits?

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QbD, the Way into the Future

Some of these new products are QbD products but they are not attracting all the attention that they deserve. In fact, QbD has been one of the biggest enablers in a new manufacturing paradigm of breakthrough pharmaceuticals. But they may only be at the beginning.

They may be early signs of that the best way to achieve the future needs for agile, flexible and robust manufacturing concepts are with the Quality by Design methodology. Some companies will do QbD submissions and others only do QbD development but submit traditional submissions because they do not consider the regulatory approval process robust enough to ensure fast QbD approvals.

So the important benefits from QbD are no longer harvested in the submission and the approval process. They are much more in the overall time to market for new products — and in the ability to provide agile and flexible pharmaceutical manufacturing systems of the future.

Manufacturing systems that demonstrate their ability to meet the market needs as well as the regulatory requirements by a set of very cost-effective and flexible manufacturing principles and are powered by — Quality by Design!

* Gert Moelgaard was Corporate Vice President Strategic Development at NNE Pharmaplan until January 2016 and is now supporting the company as Senior Consultant. NNE Pharmaplan is an international company specialised in pharma engineering.

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