With operating efficiencies increasingly dependent on 'right first time', there is a need to change the status quo in the way processes are controlled.

PAT ensures the continuous control of processes and the timely availability of quality products to market, which results in satisfied customers.

Understandably, the thought of implementing a closed-loop PAT strategy throughout the global enterprise and for all products can keep pharmaceutical executives awake at night.

In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

Quality by design and PAT approaches are increasingly being used for the biotech manufacturing of medicines. Complex manufacturing processes can not only be controlled using PAT principles, but optimized with respect to both product quality and economic value. This column describes how the fermentation process is often the first to benefit from this type of implementation.