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.".

• GlaxoSmithKline Ltd.
• Eli Lilly & Co
• Bristol Myers Squibb Co; Merck

• API

1. API
2. CMC
3. Control strategy
4. design of experiment (DoE)
5. Design space
6. ICH
7. kinetics
8. Manufacturing process description S2.2
9. Methods
10. Models
11. process
12. Quality by Design (QbD)
13. Review article