(144a) Tales From the Trail: A Continuing QbD Journey

Tales from the Trail: A Continuing QbD Journey

Quality by Design has transformed the way in which many companies approach process development.  By starting with patient needs and following a structured framework that follows the voice of the patient into an assessment of risks that may inhibit meeting those needs, then establishing process deliverables and controls, it is generally accepted that processes are better designed and are more robust as they enter commercial production.   Although it is recognized that QbD is the right thing to do for patients and customers, many challenges and barriers remain to achieving a landscape in which all products are developed and/or communicated in that framework.   For example, the lack of global harmonization, of aligned perception of residual risk, and of interpretation  of ICH guidance and supporting materials, have made it increasingly difficult to navigate the global regulatory process with a QbD submission.

This presentation will provide a case study, and outline some ways to drive QbD forward from its current crossroads.