Quality By Design: Industry Insight

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Cold Chain IQ

Pharma Logistics IQ speaks to Richard Francis, Owner of  Francis Biopharma for his expert insight on Quality by Design to find out the latest updates and forecasts for the industry.

1.What is the biggest QbD challenge for pharma companies?

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 too their own quality management system it really is.

2.How can this be addressed?

Though education, proven examples and communication from the regulatory agencies - which is coming in the shape of new guidance (ICH Q12). 

3.If this hurdle in the market isn’t solved what are the potential consequences for both the company at hand and industry?

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

4.Any case studies of QbD mistakes you have seen in your experience ?

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

5. Have there been any changes to QbD regulations or guidelines recently?

There is a new guidance ICH Q12 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.

6. Are there any regulations or guidelines which may be changing over the next 24 – 48 months?

Yes, to ICH Q12. The official ICH statement concerning ICHQ12 is; This guideline is intended to work with ICH Q8 to Q11 Guidelines and will provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. There is currently a lack of a harmonised approach on technical and regulatory considerations for lifecycle management. While the concepts in ICH Q8, Q9, Q10 and Q11 provide opportunities for a more science and risk-based approach for assessing changes across the lifecycle, several gaps exist which limit full realisation of intended benefits.

The envisioned post-approval ‘operational flexibility’ has not been achieved. The main emphasis at ICH to date has focused on early stages of the product lifecycle (i.e., development through launch).

7. Why is continuous improvement important for professionals affected by QbD regulations? – What would you say to someone who thought it was a waste to invest in continuous improvement?

The issue with the guidances is they cannot specifically define all of the requirements associated with your specific needs. So the more you develop your understanding of the guidance’s and also 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.