Quality by Design principles are well established in the pharmaceutical industry. It is becoming common place to develop the design space for a drug product and include it in the regulatory filing. There are a broad range of methods to establish design space, some of which are focused on individual unit operations and others that take a holistic view of the entire product processing. A new challenge is developing approaches for verifying the design space for commercial production, especially for those defined using data obtained from modeling or small scale experiments. In this talk, a proposal for verifying the design space for a drug product with multiple CPPs, KPPs and CQAs will be discussed using principles of scale-dependencies, use of precedented models, and (when necessary) large scale confirmation batches.
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