Quality by Design (QbD)

Implementing quality by design manufacturing workflows helps to improve the efficiency and shorten development times.

At Minakem we believe that implementation of QbD principles provides a cost-efficient approach to delivering high-quality robust processes for our customers. The Regulatory authorities, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are now placing greater emphasis on the QbD component as a part of regulatory filing. QbD has become a crucial element within Minakem for a stream-lined API process development.