Quality by Design for Generic Drugs

The US Food and Drug Administration's Office of Generic Drugs (OGD) and the Generic Pharmaceutical Association (GPhA) held a two-day workshop in June 2009 in Maryland, on pharmaceutical quality by design (QbD) for generic-drug products. The purpose of the workshop was for scientists from FDA and the generic-drug industry to discuss QbD for generic drugs in the context of the International Conference on Harmonization Q8(R1) Pharmaceutical Development and its Annex (1). The specific objectives of this workshop were to identify gaps in the understanding of QbD between FDA and industry and to build a common understanding of certain key aspects of QbD, including:

The quality target product profile (QTPP) and critical quality attributes (CQAs)
Drug substance and excipient properties
Formulation design and development
Manufacturing process design and development
Identification of critical process parameters (CPPs) and critical material attributes (CMAs)
Risk assessment and design space
Scale-up and control strategy.