Using QbD Approaches to Enable Development of Real Time Release for a Continuous Drug Product Process

QbD is now commonly used in the development of many pharmaceuticals and fine chemicals and include a number of risk management tools. Risk assessments are routinely used within Pfizer during product development and continuous improvement to identify areas where further process understanding is required. Gaining increased process understanding allows us to develop more robust and lean manufacturing processes supported by a well designed control strategy. An example will be presented which demonstrates the use of risk management tools in the development of a continuous drug product process using a real time release control strategy.