Quality by design is an essential part of the modern approach to pharmaceutical quality. But there is uncertainty in the generic drug industry about how the core concepts in ICH Q8(R1) will apply to development of generic drugs. FDA's Office of Generic Drugs has been revising its approaches to pharmaceutical quality in recent years, beginning with implementation of a question-based review process and continuing through current discussions on implementation of quality by design. In this talk, I will give examples about how the core elements of quality by design apply to generic drug development: starting with a Quality Target Product Profile, identifying critical quality attributes of the drug product, using prior knowledge to perform risk assessments for development prioritization, linking critical quality attributes to material attributes and process parameters and establishing a quality control strategy. There will be specific discussion on how some of the unique features of generic drug development make these processes different from how they may be employed in new drug development.
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