Since every patient deserves drugs that are safe and efficacious, quality is key for any manufacturer of (bio)pharmaceuticals.
But how do you know that a drug was produced in a way that its quality is up to standards? Strict regulation was put in place, known as Good Manufacturing Practices (GMP), which requires that the production process is thoroughly documented. This is where the batch record comes into play. It is this record that allows manufacturer to answer questions that are critical to product quality, such as; Who did what, and when? Which materials were used? Which procedures were followed and were the results within specifications?
What information can be found in the batch record?
The exact content and format of the batch record depends from company to company and product to product. The following elements can generally be found in every batch record:
General batch information
Each batch needs to be given unique batch number or lot number. This number serves as the unique identifier of the produced lot of medicine. Each record related to the batch should be clearly identifiable via this unique ID.
Furthermore, a precise description of the batch is required. For example, the start date and end date of the manufacturing run, the storage conditions, the batch composition, manufacturer licence number, expiry date, labelling information, etc. need to be mentioned.
Each batch record should refer to the appropriate version of the master batch record and when and by who the batch record template was issued.
The first way to ensure the quality of the product, is to make sure that the raw materials that were used in the manufacturing process are of the right quality. The whole process of receiving the material, checking the labels, the integrity of the excipients and the laboratory tests to assess the material quality needs to be documented. The Bill of Material (or BOM) lists the exact raw materials that were used, together with the quantities, exact material lot numbers and expiration dates.
Execution of procedures and work instructions
The batch record contains precise information on how exactly the product was made, which standard operating procedures (SOPs) were followed, which critical quality attributes (CQAs) are assessed and which critical process parameters (CPPs) were used.
The operators find precise step-by-step work instructions in the batch record to execute each procedure. During production, they carefully indicate (and sign off) when a specific step was executed. Any deviation from the standard procedure is carefully noted down in the batch record as well.
Note that such workflow execution records are also required for ‘auxiliary’ processes, such as the in-process quality & sterility testing and the environmental monitoring of the production environment.
Each procedure and method that has been used for any of the above activities need to be validated and the status of the validation is referenced in the batch record. Additionally, it should be verifiable that each operator was sufficiently trained to execute the procedure.
Even before the processing begins, a verification of the workspace and all equipment that will be used must be done and recorded in the batch record. This is to check that the used equipment is clean, properly maintained, correctly calibrated and suitable for use.
The manufacturing process is closely monitored. For many GMP critical steps, there might be a second operator who witnesses the proper execution of the procedures, but also afterwards the correctness and completeness of the records is verified. Special care should be taken to review each deviation from the standard procedure in order to assess its potential impact on the quality of the product. These review actions need to be logged and signed off in the batch record.
Quality of the batch record
The batch record is the most important tool to verify the quality of a pharmaceutical product, therefore, the quality of the record itself is equally important.
With sloppy batch records that are difficult to read, or mis proper identification and timestamps of the executed actions, the Quality Assurance manager or the auditor who needs to assess the quality of the product is up for an impossible task.
It is not uncommon for a complete batch record to count 100 pages, or even up to 400 pages for personalised therapies such as CAR-T! To manage this amount of information in a regulatory compliant, though time and resource efficient way, it’s important to use the right tools. Paper-based systems can be very cumbersome and error-prone. Electronic batch records (or eBRs) that are specifically designed for your GMP operations help you to spend time on the quality of the product, rather than needing to spend time on the quality of the record; the electronic batch record can do all the heavy lifting in terms of complex and time-consuming paperwork, data integrity checks, analytics and report generation.
Read here what the 7 key requirements of an effective electronic batch record are and learn how data integrity, 21 CFR 11 compliance and user-friendliness go hand in hand. To learn how MyCellHub can help you digitalise your GMP workflows, schedule a demo with one of our experts here: