What is an electronic batch record?
Electronic batch records (EBRs) are digital tools that track and monitor batch production throughout the manufacturing process.
Unlike manually curated paper-based records, EBRs automatically capture data in real-time and verify processes. This streamlines batch manufacturing, reduces the likelihood of human errors, and allows life science companies to improve compliance.
With Pharma 4.0 disrupting the life sciences industry, and disrupting how companies interact with their environments, share data, and execute processes, EBRs are becoming increasingly popular. These digital records minimize resource waste and optimize production. As a result, organizations save time and money, while bringing therapies to market in a fraction of the time.
Batch records, EBRs, and MBRs: What's the difference?
If you’re wondering what the difference is between electronic batch records (EBRs), batch records (BRs), and master batch records (MBRs) — you aren’t alone. The distinctions aren’t always straightforward.
In some cases, EBRs and batch records are used interchangeably and mean the same thing. At other times, batch records refer to the paper-based documents that contain certain steps taken to manufacture a specific batch of drugs while EBRs specifically refer to the digital version of these documents and the electronic means of capturing the needed data.
Conversely, master batch records (MBRs) provide the full record of how a drug is made, including detailed instructions for every step that needs to be taken along the way. These records act as a master recipe for operators to follow and replicate.
To maintain compliance with cGMP regulations, regulated companies are required to create and maintain master batch records. These records provide evidence of safe manufacturing during the production process of every batch, and are often referenced during FDA audits.
What are other names for electronic batch records?
As mentioned above, sometimes electronic batch records are also simply referred to as batch records. However, there are also other terms used for EBRs, including:
- Batch formula records
- Batch manufacturing records
- EBRs in manufacturing
- Electronic batch record solutions
What are EBRs in pharma?
Electronic batch records in pharma are digital tools that track and monitor the drug manufacturing process for specific batches.
EBR solutions are designed to capture data accurately, and in real time, thereby mitigating process deviations and transcription errors. Plus, electronic batch records help pharma companies maintain the integrity and purity of their products by improving visibility throughout the drug manufacturing cycle. With every step recorded — in detail — batches can be released sooner without compromising quality or safety.
Why are EBRs important in pharma?
Electronic batch records are important in pharma because they improve accuracy, decrease costs, and increase productivity. Through detailed, automated record keeping, every stage of the production process can be monitored and resourced, helping to maintain compliance and minimize costly deviations.
Electronic batch record systems help pharma companies reduce the time it takes to manufacture a therapy, while also ensuring drug quality and purity. While alternatives such as Electronic Laboratory Notebooks (ELNs) exist, they lack the programmable guardrails needed to ensure the needed parameters are met at every step.
Ultimately, EBRs give pharma companies more control over quality processes, provide users with process and deviation data, reduce cycle times, and accelerate time to market.