Developing a Retrospective QbD: a ValGenesis Story


Who doesn’t like a good story? Well, we have another for you!

This time, we want to tell you how we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective Quality by Design (QbD) methodology. Are you curious about it? Let’s check this out.  


Let’s Know What Happened! 


The company in our story faced some issues in managing the Post-Approval Changes of a legacy product. It happened due to the non-existence of formal Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) assessments. Or, in other words, due to not having a QbD framework. 

Not having a QbD Framework caused an impact on the processes and brought some consequences, such as

  • Lack of Control Strategy Robustness;
  • Less Regulatory Flexibility;
  • Gaps in Process Knowledge.

So, because of that, they decided to look for help. And guess who gets it on the act? Yes, that’s right, us! 


How Did We Help the Company?  


For situations like these, our go-to solution is to apply a Retrospective QbD.  

We apply this methodology to products at a later stage of development or to products already in the commercial phase.  

The starting point was analyzing the process development available information as well as the whole manufacturing history, in collaboration with a subject-matter expert (SME). A  risk assessment was performed to analyze the dependencies between critical quality attributes and critical process parameters. With this, knowledge gaps in the process could be identified.

Following all these steps, allowed us to define the Quality Target Product Profile (QTTP), CQA’s and CPP's. That was essential to design and implement a control strategy! 


Did the Company Benefit From our Retrospective QbD Approach? 


With our intervention, it was possible to have a formal criticality analysis of the current process based on process historical data. 

These formal risk assessments made the company improve the product’s control strategy and have a better understanding of the Chemistry, Manufacturing and Controls (CMC) elements as well.   

And what is the main benefit? You ask.

Well, with a Retrospective QbD implementation, the company is now able to build a Continuous Process Verification plan and, finally, develop faster and efficient Post Approval Change Management Program that is both science and risk-based.


We Have Some Experience in Implementing a Retrospective QbD


If you have a product in a commercial stage that doesn’t have a QbD Framework, we’ve got the expertise to help you. Take a look at our Retrospective Quality-by-Design solution and feel free to contact us