Electronic batch records (EBR) play a crucial role in the safe manufacturing process of drugs and other pharmaceutical products. In an industry where auditability and compliance are everything, detailed, verifiable records form the backbone of the manufacturing process. In the Current Good Manufacturing Practices (cGMP) as defined by the Food and Drug Administration (FDA), electronic batch records feature prominently as the bedrock of compliance for pharmaceutical manufacturers.
So, what are electronic batch records? And how do they fit into the compliance, and more importantly safety, of pharmaceutical manufacturing? In this article, we will examine the origins of electronic batch records in pharma, take a look at the regulations and compliance which they support, and provide an overview of the tools which are used to create and manage them.
What is the Difference Between a Batch and a Lot?
You may have used the term “lot” used when referring to pharmaceutical manufacturing, as well as “batch.” Before we examine pharmaceutical electronic batch records in more detail, it is worth understanding what a batch is, and how, if at all, it differs from a lot.
According to 21 CFR Part 11, a batch is defined as “ a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.” So, batches are a defined quantity, anywhere from one to thousands, of a drug, supplement, or medical device that is covered by 21 CFR Part 11.
Lots, on the other hand, are defined as “a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.” Essentially, the term “lot” can be used interchangeably with batches in some cases, but specifically refers to a defined portion produced during a specific period of time, thereby making ‘lot’ the more commonly used term when referring to drugs produced via continuous process.
As you can see, in the context of pharmaceutical manufacturing, batch and lot are essentially interchangeable terms. Importantly, electronic batch records can apply to both batches and lots, and the title for them does not change.
What is an Electronic Batch Record in Pharma?
Batch Manufacturing Records (BMR) or Batch Production Records (BPR) date back to well before the advent of computers and digital records. Used in all forms of batch manufacturing, they are the documentation of what went into a batch, who was involved in the manufacturing of the batch, the batch number, and more. Despite being used in many manufacturing processes, the term has become particularly synonymous with pharmaceutical manufacturing, where ensuring the safety and provenance of each batch can be a life or death matter, both for the company and its customers.
Electronic batch records contain all the same information but are generated automatically by, and stored on, a digital EBR software platform. These platforms integrate into the manufacturing process and record every action taken, the materials and devices used, and the persons involved in the manufacturing process for each batch. All of the data points that are required to prove compliance in the case of an audit by the FDA.
Originally, batch records were maintained on paper in massive quantities, with master batch records for each product, batch records for individual batches, and duplicates thereof. Naturally, for large scale pharmaceutical manufacturers, this meant dedicating a huge amount of time and storage space to creating and managing batch records. As soon as EBR software became available, they were eager to transition to using these systems. Unfortunately, for some time they still had to maintain physical batch records to meet FDA compliance. In 1997, however, the FDA approved EBR systems as compliant with the passage of Title 21 CFR Part 11
Electronic Batch Records & GMP
Good manufacturing practices are the quality assurance guidelines and processes that underpin the FDA’s regulatory framework for pharmaceutical and medical device manufacturers. They define how each step of the manufacturing process should be conducted and, more importantly, how it should be recorded. For companies to ensure that they are meeting compliance, and for the FDA to be able to verify that, each action taken in the quality assurance process must be recorded.
The most important part of cGMP is the ability to prove and verify that the other elements of cGMP have been adhered to. Electronic batch records, therefore, are critical to the entire cGMP infrastructure. Not only the information contained within them also but the way in which they were produced and how they are stored and managed thereafter.
Batch Record Management
As we have already touched on, batch record management has always been a complex issue for the pharmaceutical and medical device industries. Prior to the introduction of EBR systems, this was particularly true, with hard-copy documents requiring regular review and approval. Naturally, this was a hugely inefficient way to manage pharmaceutical batch records and was highly prone to errors. Batch records should always include:
Master Production and Control Records (MPCR)
Batch Production and Control Records (BCPR)
Bill of Materials (BOM)
General manufacturing instructions
Equipment cleaning record
Time-stamped history of changes
While still a complex process today, the management of batch records is now largely automated by electronic batch records software. EBR software platforms, or other electronic records management systems that offer EBR functionality, build the creation of accurate, auditable electronic batch records directly into the manufacturing process, removing the need to spend huge amounts of time documenting the manufacturing process. Some of the key benefits of implementing electronic batch records software include:
Massive improvements in production efficiency
Far less storage space required for documentation
In-built compliance, eliminating the risk of human error
Controlled issuance of batch records
Integration with other systems
Instant analytics and reporting
MES & Electronic Batch Records
Manufacturing Execution Systems, or MES, became widely adopted in the pharmaceutical industry around the same time as EBR systems when CFR 21 Part 11 came into effect. While EBR systems refer to specific pieces of software that are exclusively designed to produce and manage electronic batch records, manufacturing executions systems refer more to an overarching system governance for the manufacturing process that may involve multiple pieces of technology and software.
MES projects will always include an EBR platform as part of their foundation, but will generally build on that by integrating Enterprise Resource Planning systems, automated weigh and dispense systems, production scheduling, and more. The goal of MES is to centralize the control of all aspects of the manufacturing process, including compliance, to allow for greater visibility of the manufacturing process and increased interoperability with other departments such as quality assurance or operations.
Electronic Batch Record Example
It may seem like the easiest way to get a clear understanding of what electronic batch records are, and how they function, would be to see an electronic batch record example. Unfortunately, it’s not that simple. Although every electronic batch record must have all the same components to be compliant with cGMP and FDA regulations, the actual details of a batch record will vary significantly depending on the software that was used, the industry it is from, and the specifics of that manufacturing process.
The best option to get an example of an electronic batch record would be to do some research into available EBR systems, find one that is widely used in your industry or seems like it would meet your needs, and then reach out to their sales team to request a demo. Most EBR management software companies will be more than happy to arrange a walkthrough of their platform.
Batch records are essential. Without them, it is impossible for a pharmaceutical manufacturer to prove that it has adhered to cGMP. Prior to the passage of 21 CFR part 11, they had to be maintained manually, using hard copies. The acceptance by the FDA of electronic batch records represented a huge leap forward for the pharmaceutical and medical device industries, allowing for huge improvements in operational efficiency and significant reductions in storage space and cost.
With EBR systems now industry-standard, there are a huge number of offerings. Some focus specifically on EBR, while others integrate compliance-ready EBR functionality into a broader records management or manufacturing execution system. Others integrate seamlessly with other software systems, while some don’t. It is therefore important to evaluate the records management needs of your organization as a whole when considering which EBR system to go with.