In our News from 1 February 2012 we already reported about the FDA requirements for generic drug manufacturers and also referred to a QbD case study for solid dosage forms (107 pages).
In the meantime the FDA has issued the second case study for a product with modified release (161 pages).
At the same time the Gold Sheet from June 2012 reports that the requirement for application of QbD has to be implemented in January 2013. From then the FDA will not process any authorisation applications for generic drugs that do not consider the QbD approach in development. There are a number of questions the applicant has to answer now in every section of the Quality Overall Summary.
The FDA maintains a checklist for reviewing the applications to see whether they are complete and acceptable for further processing. It has to be proven that generic drug manufacturers conducted QbD studies before submitting the authorisation application.
To find out more please also see the FDA Case Study entitled "Quality by Design for ANDAs: An Example for Modified Release Dosage Forms".
Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)