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Pharma Solid Knowledge Report: Automated Process Development (APD)

Quality by Design (QbD) was introduced by the American FDA in the ICH Q8 (R2) “as a new paradigm with significant effects on current and future trends in pharmaceutical development (2004).” QbD describes good practice for pharmaceutical product development and introduces concepts of design space and flexible regulatory aspects. It is a systematic approach to development, emphasizes product and process understanding, as well as process control.

To read Bosch’s mini white paper on this topic, click here.

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