The Delivery of Flexibility from the Application of QbD to API Development

This paper by IQ consortium member companies will describe how the application of the ICH Q11 vision for enhanced QbD development can lead to flexibility through differentiated outcomes for elements of API manufacture, such as the control strategy and lifecycle change management. Two further articles, in addition to this introductory paper, will present a series of case histories which address such flexibility and exemplify opportunities for the further development of the ICH Q11 vision.