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Quality By Design: The Automated Pharmaceutical Assay
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This paper provides a very brief overview of Quality by Design in the Pharmaceutical Industry focusing down to the pharmaceutical assay. Example flow charts are used to highlight areas for improvement in the traditional pharmaceutical assay method. A flow chart displays areas that are improved by automation. Keep types of failure are discussed and specific ways that automation provides a better assurance or quality by the design of the method. These improvements can build on each other providing a near Bullet Proof level of assurance.
