Sushil K. Srivastava

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.

Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description

A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API supply chain and control strategy, and how changes to such outcomes are managed over the lifecycle. A series of articles will address “flexibility” and look to provide recommendations for the further development of the ICH Q11 vision. The focus of this work will address flexibility associated with the “Enhanced Approaches to the Development of the Control Strategy and Its Implementation in the Manufacturing Process Description.”