FDA: QbD becomes mandatory for Generics

Starting with January 2013, the U.S. Food and Drug Administration (FDA) expects generic drug manufacturers to implement Quality by Design (QbD) into their Abbreviated New Drug Applications (ANDA), Module 3 Quality 3.2.P.2 Pharmaceutical Development.

To support generic manufacturers, the Office of Generic Drugs (OGD) has published a 161 page example of a fictitious modified release tablet formulation.

"The purpose of the example is to illustrate the types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their development process and to promote discussion on how OGD would use this information in review.
Although we have tried to make the example as realistic as possible, the development of a real product may differ from this example. The example is for illustrative purposes and, depending on applicants' experience and knowledge, the degree of experimentation for a particular product may vary", the U.S. authority states in its introduction to the document "Quality by Design for ANDAs: An Example for Modified Release Dosage Forms".

Another example on an immediate release tablet will follow.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)