Quality by Design, ICH Q8, ICH Q9, ICH 10, Real time release, Continuous manufacturing, Batch manufacturing, critical material quality attributes, process models
Regulatory guidelines are changing product quality focus from a reliance on end product testing to a Quality by Design (QbD) approach across the entire pharmaceutical product life cycle. The introduction of QbD elements to pharmaceutical manufacturing has the ability to speed up the time to market by facilitating scale-up during product development, enable real time release (RTR) and reduce the risk of batch failures. Pharmaceutical manufacturing approaches to make plants more efficient and flexible include a move towards continuous manufacturing platforms. As continuous manufacturing processes have no defined batch size, proving rigorous process control and fault detection is crucial to validate these processes. Continuous manufacturing therefore requires that a much greater burden is placed on tight process control. To achieve this level of control, in-depth material and process knowledge is required. QbD principles are therefore essential to ensure process control during continuous production.
This article introduces and discusses the regulatory principles of the QbD approach across the pharmaceutical product life cycle. It explores the role of QbD within an evolving pharmaceutical manufacturing sector. The implementation of QbD is discussed together with the concepts of quality target product profiles, material quality attributes, process parameter control, design space, process models and process analytical technology.