Keynote address: Making sense of good quality by design in the 2020s

The second day of the inaugural Pharma LabNext Conclave, on the theme ‘Pharma Labs: The Next Frontier’, commenced with a Key Note Address by Dr Ajaz S Hussain. Dr Hussain drew from his experience of over three decades in the pharma sector in various roles, i.e. as a professor/academician, a regulator, a pharma professional and a consultant, to give his insights on ‘Making Sense of Good Quality by Design in the 2020s.’

He gave an overview on how global realities are changing and the need for the pharma industry to keep pace with them. He also said that to become future-ready, it is important to improve traceability and integrity. He said Industry 4.0 stressed that by 2030 there is an aim to remove humans for current Good Manufacturing Practices (cGMP) to reduce errors. And, we need to do this by leveraging sensemaking and investing in the right technologies. These technologies will help the industry to learn from its experience and self-transform for the better. He also informed how Quality by Design (QbD), especially analytical methods, is a key area of focus today. He went on to elaborate on digitialisation in the pharma/biopharma sector and said that the five maturity levels of a ‘Smart Factory’ are, Pre-Digital Plant, Digital Silos, Connected Plant, Predictive Plant and Adaptive Plant. Currently, most big biopharma companies are at Level 3.

He concluded that we are born and live in socio-technical systems but, the COVID-19 tragedy has broken our systems. We need to build back and go through a reset to thrive in a complex environment. Quality by Design will have a key role in rebuilding these processes and systems.

His session, thus addressed various aspects of pharma quality and regulatory compliance.

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