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Streamlining Process Characterization Toward Successful Validation Campaigns

Summary: Process characterization is an important step in the product development journey. The drivers for process characterization and late-phase development include improving process understanding, enhancing robustness, and assurance that it delivers consistent product quality within the characterized or proven acceptable ranges. This is further exacerbated by demanding timelines imposed by rapid progression from phase 3 to filing.
Although different approaches for process characterization have been taken, they contain many common elements including risk assessment, scale-down model qualification, and statistical design of experiments. However, there is not a consensus on criteria for the selection of a unique or multiple experimental designs for the evaluation of Critical Process Parameters at every stage.

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