For companies in the life sciences, healthcare, cosmetics, or any other strongly regulated industry, the quality by design principle can add strong value to the overall control strategy of processes and products.

This whitepaper describes the advantages of a thorough QbD methodology, discusses the importance of a step by step plan and provides help on how to implement a QbD methodology. But before we start, it’s first time to eliminate a kind of misunderstanding around QbD.