Quality by Design: How to Harvest the Benefits?

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A Hidden Business Secret is lifted

Actually it is doing well in a very important area of the pharmaceutical industry, namely among some of the most innovative companies that are setting the agenda of the future. As a matter of fact, QbD is almost like a hidden business secret behind some of the fastest pharmaceutical product approvals of all time — and is hidden within some of the most successful new manufacturing facilities using continuous manufacturing of pharmaceutical products.

The reality is only that it has become less of a buzzword and more of a daily reality. Now it is just a part of business in some of the largest pharmaceutical companies in the world — and in some of the most innovative of the small or mid-sized companies.

There was always more enthusiasm around QbD in the US than in Europe and Japan although the ICH guides were implemented in all of them — and other countries, too. The fact that FDA promoted it as the “desired state” and was driven by visions such as “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight” and the fact that FDA engaged actively in examples and cooperations with industry on the guidance has given a momentum that Europe can only wish for.

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