This is a happy story about Risk Management and Process Optimisation. 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 4TE entered the project, we went on to draft a strategy.

First, we wanted to identify what were the controlled variables with impact in the coating time. And from there we wanted to optimise 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 Optimisation? 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 analysing 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 optimise 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

4TE has solid expertise with Quality Risk Management Optimisation and we deliver it through one of the best QRM platforms in the market.

We recommend that you check our QRM Process Optimisation 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.

Related topics

If QRM is a topic of interest to you, we recommend you checkout this article of ours: QRM over Lifecycle Management.