Electronic Batch Records: Beyond paper on glass record systems

This article looks at the advantages of replacing paper batch manufacturing records (BMR) with electronic batch records (EBR) in pharmaceutical manufacturing.

Pretty much every paper based system today has been replaced with electronic versions, so the switch from paper BMR to EBR probably sounds relatively simple. If this is what you think then the chances are, you have never worked in the pharmaceutical manufacturing industry. The industry does not do simple, it does complex and challenging, that is why the industry is inhabited by some of our greatest minds. BMR serves the purpose of documenting the manufacturing process of every batch of product made. It must include ingredients (including batches & weights), equipment used, people involved, quality checks that were made and various other pieces of critical information. The reason for all this is down to one thing, patient safety. Patient safety is paramount and therefore the documentation relating to batch manufacturing must be accurate, eligible, retrievable and it must be recorded via an approved and validated method. The validation of the record system must ensure all the key features of the BMR are met so a paper on glass version will need to be bullet proof.

Do not be fooled at this point, EBR in the pharmaceutical industry is not a new thing any many manufacturers have already successfully adopted this method with FDA approval. This article isn’t trying to convince its readers of the benefits of replacing paper based BMR with EBR, that’s obvious for all to see. No, this article exists to point out why the like for like switch from paper to glass is only scratching the surface of EBR capability.

Pharmaceutical manufacturing requires a few things. It needs materials that have been quality inspected or tested and released for use. It needs equipment that has been well maintained and validated. The product needs to be tested at various stages to ensure it is safe and of the right efficacy. The whole end to end process needs to be documented, fully traceable and, everyone involved at any stage must be sufficiently trained. There are many more activities and stages to the process but already with those mentioned it is clear that there are a lot of failure points. Many of the manufacturing related processes such as machine maintenance and validation, training, quality testing and sampling, inventory management and resource planning use a separate system to the other and often are not integrated in any way. Whether a manufacturer is using a paper based or electron batch record system it is usually standalone from the other systems mentioned. All these different systems are acting as the ingredients list for a recipe of error and waste. What’s more, it doesn’t have to be this way as the technology to pull it all together exists.

Your EBR should prevent users completing processes where their training has not been completed or has expired, by linking into the employee training database. If machine maintenance has been missed or validation has expired, the EBR system will know and flag it before the batch scheduled for the machine has even been made. By communicating with inventory management and materials planning systems such as ERP & MRP in real time, material shortages and over ordering would become a thing of the past. All this would prevent common compliance errors from ever occurring leading to improved product release time and a reduction in waste. EBR would not require all other systems to be changed in order to harmonise, instead it would use a multi-agent system to pull them all together.

The capability to do all of this is out there through systems created by leaders in EBR such as EMERSON and Siemens yet most pharmaceutical manufacturers are not even close to harnessing the power of this technology.