Quality-by-Design: Industry insight

Pharma Logistics IQ speaks to Richard Francis, owner of  Francis Biopharma, for his insights on Quality-by-Design (QbD) in pharma manufacturing and the supply chain. 

Pharma Logistics IQ: What is the biggest QbD challenge for pharma companies?

RF: Understanding the value proposition. The key is that following the systematic approach within QbD or an enhanced pharmaceutical development approach (as defined in the ICH Q8 and 11 guidances) the company will develop a more robust understanding of both process and product. Such an understanding is critical for maintaining product quality and supply of the product to patients.

This is the true value of a QbD approach and still many companies are yet to understand this benefit, as they view it as a regulatory agency-driven program and not the foundation tool their for own quality management system it really is.

Pharma Logistics IQ: How can this be addressed?

RF: Through education, proven examples and communication from the regulatory agencies - which is coming in the shape of new guidance. 

Pharma Logistics IQ: If this hurdle in the market isn’t solved what are the potential consequences for both companies and the industry?

RF: Continuing drug shortages, increased risk to patient safety, increased regulatory agency enforcement and a general decline in the pharma industry. 

Pharma Logistics IQ: Are there any case studies of QbD mistakes you have seen in your experience ?

RF: The joint FDA /EMA QbD submission program and the lessons learnt from the Roche Pejeta QbD submission along with the expectation of the design space definition are both very useful.

Pharma Logistics IQ: Have there been any changes to QbD regulations or guidelines recently?

RF: There is new guidance that will of course be useful to address many issues. Additionally, the FDA guidance relating to defining Established Process Conditions in relation to an overall process control strategy is also of significant use.

Pharma Logistics IQ:  Why is continuous improvement important for professionals affected by QbD regulations, and what would you say to someone who thought it was a waste to invest in this? 

RF: The issue with the guidances is that they cannot specifically define all of the requirements associated with your specific needs. So the more you develop your understanding of the guidances and examine how others in your industry interpret and use them, then the greater your capability will be to direct and manage the regulatory expectations. Without that capability the reverse will be true, hence the importance of knowledge in this ever-developing and changing area.