Quality-By-Design Q&A

US FDA and the EMA are publishing a series of joint question-and-answer documents that outline the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application. One of the projected outcomes of this pilot was to share key findings with the public.

FDA and EMA will publish additional question-and-answer documents on other QbD-related topics as the pilot program continues and more parallel assessments are conducted. Both agencies found the parallel assessment useful and reached agreement on a wide range of QbD aspects. At the request of the applicant, experts from the Japanese Pharmaceuticals Medical Devices Agency also participated as observers in this first parallel assessment.

For further details see FDA

Posted by Tim Sandle