Risk Management and Process Optimization: a ValGenesis story

risk-management-and-process optimisation-a -4TE-story

This is a happy story about Risk Management and Process Optimization. But it’s also confidential in some parts, which is why we changed names and locations. But don’t worry, we didn’t change any details.

A Bottleneck in the Process

Our story starts somewhere in central Europe. Our main character is a large pharmaceutical company with several sites spread over the continent. We’ll call it PC (as in, Pharma Company).

PC had a very well-established Process running for oral dose medicine that had been running for more than 15 years.

The main issue was that the coating part was taking a lot of process time. About 51%. And that was a problem for business. Why? Because it was creating a production bottleneck.

A Strategy for Success

When ValGenesis entered the project, we went on to draft a strategy.

First, we wanted to identify what were the controlled variables with an impact to the coating time. And from there we wanted to optimize them.

But more than that, we wanted to implement a tool that would allow us to monitor the coating process. We went with a Process Analytical Technology tool – or PAT, if you prefer.

Quality Risk Management Process Optimization? Present!

Cooking with other people is always fun. And that’s what we did here.

We joined forces with PC and started selecting variables and analyzing historical data. For that, we used Multivariate Data Analysis – also known as, MVDA. That gave us insight on what was out of place.

From there, we performed a Design of Experiment at bench scale. We also went on to optimize the process parameters using, you guessed, Quality Risk Management.

Finally, we scaled it up and performed process validation at commercial scale.

What Did the PC Get Out of This?

We’re glad you asked!

So, the first gain, it was the fact that there was no need for post-approval changes. Having to submit less documents is always good!

Then, we had the second gain. This was a significant improvement of coating process understanding, all thanks to the PAT tool we implemented. It also meant that the final product’s Critical Quality Attributes – CQAs – were kept well under control.

But the real star outcome was the following: Coating time was reduced in 50%. Indeed. This meant a significant efficiency increase in all the product lines depending on this part of the process.

We Can Help You Too

ValGenesis has solid expertise with Quality Risk Management Optimization and we deliver it through one of the best QRM platforms in the market.

We recommend that you check our Process Optimization Services. If you think we may be able to help you out, don’t hesitate to book a call, we’ll do our absolute best to help.

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.