3 Key Trends in PAT / QbD Implementation



Peter Boogaard
04/11/2013

Peter Boogaard, Founder of Industrial Lab Automation and Director at Vialis AG recently gave a workshop at the recent 10th anniversary Pat & Quality by Design Conference which recently took place in London. He gives an overview of the top takeaways from this event.
 
This year’s program included many case studies and general trends in the QbD and PAT adoption, but there were three particular topics that triggered my attention.
 
  1. Driving the need for constant product innovations in a legislation-complex industry remains a challenge in the life sciences industry. Quality should be built into the design throughout the specification, design and verification process. The consumer demand becomes more sophisticated, in both the innovative pharma and generics side if the industry. During breakout discussions at the conference, it was obvious that the drivers for both pharma segments are different. The traditional pharma industry is focusing on new product innovation while the generic industry is concentrating on optimizing production to reduce costs with manageable predictive quality. It seems implementing QbD within the generic industry has many similarities with other industries such as consumer packaged goods and electronics.
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  3. It may seem a boring topic these days, but the need for standardisation in our industry has never been higher. Forums like this conference presents a valuable opportunity for so many people from different regions, job functions and seniority to come together to discuss how the industry can evolve these and make it happen. Both John Purves, former head of EMA and Lawrence Yu, Deputy Director of the FDA, presented the notion that regulators are more familiar with QbD than some years ago. Instead of discussion “why QbD”, the focus was centred on  “how can we make it happen”. A point of attention was raised for standardisation in nomenclature and naming convention to avoid miscommunication across industry and regulators.
     
  4. The term QbD and PAT are becoming mainstream in our industry, however recent research from Pharma IQ showed that 68% of individuals surveyed are in the early stages of implementing QbD and lack the expertise to fully implement into all processes. Quality should be built into the design throughout the specification, design, and verification process. There is still a lot of education to be done across the different disciplines within organizations. The ICH Q10 guidelines clearly defines that a modern quality system assures science and risk-based drug manufacturing and quality decisions throughout the lifecycle.
Steps towards this were taken at this year’s PAT & QbD anniversary congress, and I look forward to continuing the discussion and progression at next year’s event.