Benefits of Electronic Batch Recording in Pharma

In this video, Uwe Rauschenberg, Track & Trace expert at Engineering Industries eXcellence, discusses the importance of electronic batch recording (EBR) in pharmaceutical manufacturing. He highlights the key reasons for EBR, including regulatory compliance, quality control, product safety and supply chain integrity. Uwe explains how EBR reduces manual errors, enhances data accuracy and cuts costs by automating processes. He also emphasizes the benefits of integrating EBR with existing systems for faster data analysis and reduced time to market.

Full Video Transcript

Hello everybody and thank you very much for attending today. In the next 10 minutes, I would like to guide you through some information around electronic batch recording in pharmaceutical manufacturing. But first of all, I need to introduce myself. My name is Uwe Rauschenberg. I'm a track and trace enthusiast at Engineering Industries eXcellence and I take care of the pharmaceutical industry in the EMEA region for track and trace.

Batch recording: I guess everybody knows about and has insights and information on it. But perhaps let's start at the very beginning. Why do we do batch recording?

First of all, the most important reason is to be compliant. Regulators say you need to follow up your batches, like in North America with the FDA, and in Europe the EMA is requiring this. Beside that we have the World Health Organization putting these into their standards of good management practices for the pharmaceutical industry worldwide. Besides being regulatory compliant, which is the most important, the second important reason for doing batch recording is quality control. Every batch needs to be quality controlled. We need to follow up which batch follows the supply chain and ends up in the manufacturing in which product at the very end.

Why is this being done? This is very important for Product Safety. Product Safety is important worldwide to avoid any substandard ingredients in the pharmaceutical products and be able to trace back any single batch when there any problems in the end product at the next point. Supply chain integrity is just as important to the manufacturer, as well as quality control. Here in the supply chain, it is important to be able to trace back your products, to trace back the batches which ended up in your products, to avoid counterfeiting and to avoid diversion, which is a major problem in many areas of the world. That's why it is a part of the good management practice.

As a manufacturer, you have advantages on batch recording as well. You can have your parts of your inventory management, which is a better overview for your inventory, by following up compliance rules, and this gives you additional advantages to comply with other regulations. Point number five of these important points on batch recording is pharmacovigilance. Many regulators worldwide are asking the pharma manufacturers to do pharmacovigilance, collecting information out of the markets and when there are errors coming up or problems being seen in this data, you need to be able to trace back the single products and be able to show what's going on. This leads to a lot of work on the manufacturer's side and there are still in the market several manufacturers who do this work the analog way, having paper on your production side and following up paper-based listings on your batches. And last, you need to take all these lists and put these data into bigger lists to be able to have these reports ready for every audit which will be done by the authorities or being able to trace back when it needs to. And everybody can imagine or knows from own experience, this causes a lot of manual efforts.

And this is one of the next points: manual efforts. When you do manual work in processes in the industry, everybody knows that there is risk for errors when you follow up manual processes and here comes the electronic batch recording into place. The advantage of electronic batch recording is that most of these process steps are automated. You have no manual efforts here. You have no human errors as you have everything automated. This gives you an automated taken data trail and this data trail is ready for any compliance audit your company has. You can automate the task, you have the possibility of a faster data analysis, a higher quality as there are less errors, and very important, it is cutting costs for the company.

What are the main reasons why it is cutting costs? You reduce time to market as you save a lot of time by doing this in an electronic way. You avoid manual labor. You avoid errors throughout the complete production process when doing the batch recording in an electronic way.

Now there are several companies using a third-party system for their electronic batch system. Why third party? Because it is another company offering these services than the company where your production equipment is from or where your ERP system is from. And here it comes to the point that when putting everything together integrated in your system, which is already connected with all other data pools, you have a faster overview, faster data analytics and lower costs.

So, giving room and giving ideas for thinking, Engineering Industries eXcellence is happy to help if you have any question on putting electronic battery recording in your pharma production area. Thank you very much.