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 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 CQA and 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 analysing the process development available information as well as the whole manufacturing history.  

After that, it was necessary to consult subject-matter experts (SME’s) and knowledge platforms, which led us to the Business Intelligence: a procedure and technical infrastructure that collects, stores, and analyses the data produced by the company activities. 

Following all these steps, allowed us to define Quality Target Product Profile (QTTP) Critical Quality Attributes (CQA’s) and Critical Process Parameters (CPP).  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 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 QbD Services and feel free to contact us! 

Want to know more? 

To know more about the importance of QbD Frameworks in the processes, you can check out our post on Accelerate the time-to-market using a QbD Framework: a 4TE Story