When it comes to manufacturing pharmaceuticals quality is critical. Following current Good Manufacturing Practices (cGMP) can help ensure that nothing goes wrong, as these practices lay the foundation for creating quality products. In most countries, cGMP is one of the conditions a company must meet to be allowed to sell its products in one jurisdiction or another.
Any deviation from the standard operating procedure could result in the release of contaminated medications or worse, which could result in the loss of an entire batch of product, leading to potential drug shortages and lost profit, among other things.
Types of Batch Records in Pharmaceutical Manufacturing
The batch manufacturing record (BMR) isa document containingthe instructions that must be followed when manufacturing medication. It includes information like product name, weight and count of each component in the medication, a list of all processes and procedures to follow, and the expected yield of each batch. Essentially, the BMR is the template for producing a drug and so it must be followed with precision and care.
What is a Batch Production Record?
Unlike the BMR, which outlines the manufacturing process, the Batch Production Record (BPR) is a complete history of each stage of the pharmaceutical manufacturing process for each lot, or batch, of medication produced. In essence, it’s a kind of checklist to ensure the instructions in the BMR are followed by everyone involved in the manufacturing process. It exists to provide proof that the BMR was addressed, which is key because, as the FDA states in their guidelines, “If it’s not written down, it didn’t happen.”
Why are BMRs so important?
BMRs detail the manufacturing process to ensure it is efficient, successful, and compliant. Those involved in the process have accurate instruction on things like maintenance, product components preparation, and quantities, among other things.
The Anatomy of a Perfect Batch Manufacturing Record
While the details are different for every product that is produced in a manufacturing facility, the required details of a BMR are the same.
Streamlining Batch Records Review with eBMR & What’s Next
Current practices for BMRs involve a lot of paper records (yes, spreadsheets are still considered paper). These, along with being time-consuming to fill out and manage, don’t give manufacturers easy access to invaluable data. Data they can use to streamline processes and reduce costs, while improving the quality of their batch runs.
Batch Management Dashboard
When you combine the information collected during the manufacturing process with data from the rest of the company, you unlock the potential that all of that data contains. By analyzing all of this combined data, it becomes possible to find operational efficiencies that can help streamline the manufacturing process, reduce costs, and help eliminate human error.
Taking steps towards the future
With the right technology in place and a healthy attitude towards digital transformation, it’s possible for pharmaceutical manufacturers to grow their business. It’s not only about creating a better batch production instructions and documentation processes. It’s about growing the bottom line.
Dot Compliance offers a feature-rich quality assurance and batch record management suite with record-fast deployment speeds and cutting-edge analytics capabilities. Contact us for a demo and discover how our quality management system can help you grow your business and maintain compliance.