What Is a Master Batch Record?
A master batch record (MBR) provides specific instructions for how to manufacture a regulated product, such as a therapy or medical device. As the name suggests, it is the “master” recipe to be referenced when creating a specific product batch instance.
When pharma companies outsource to contract and development manufacturing organizations (CDMOs), are acquired, or are manufacturing drugs in another location, part of the handover process involves providing relevant organizations with a master batch record to ensure drugs are manufactured safely, and compliance regulations are met.
Master Batch Record vs Batch Record
Both master batch records and batch records are records containing detailed manufacturing instructions for a specific product. As such, there is often confusion about the difference between these two terms.
A master batch record acts as the main document that outlines how to accurately manufacture a specific drug or device, step by step.
In contrast, operators construct a batch record during the manufacturing process. The goal of the batch record is to successfully and accurately replicate the MBR for a specific batch of product.
Why Are Master Batch Records Important?
Maintaining MBRs is essential because it ensures that any deviations from the master batch are recorded in detail, and allows companies to refer back to batch-specific data in the event an issue arises.
Furthermore, the FDA requires that both master batch records and batch records be kept by pharma companies to comply with cGMP regulations.
What Are Other Names for Master Batch Records?
Master batch records are also referred to by a variety of names, including:
- Master production records
- Master records
- Master manufacturing formulas
- Master formula records
- Master packaging records
- Batch formula records
- Batch manufacturing records
- Batch packaging records
What Is a Master Batch Record in Pharma?
A master batch record in pharma acts as the detailed instructions for how to manufacture a specific product at scale. Pharma companies send MBRs to their CDMOs and share them internally across teams and locations.
The information contained within a master batch record includes:
- Specific manufacturing process information
- General manufacturing instructions (including health and safety)
- Equipment cleaning requirements
- List of all raw materials necessary and the quantities of each
- Expected yield of each batch
- List of abbreviations operators need to know
- Revisions, changes, and associated dates
The master batch record is what allows pharma companies to mass produce batches across locations and geographies safely, and without issue or delay.
Why Are Master Batch Records Important for Pharma?
A master batch record is important for pharma because it acts as a master recipe that allows companies to mass produce batches safely and effectively. It contains all of the relevant information needed to reproduce a specific drug or device.
Master batch records provide drug development and manufacturing companies with step-by-step instructions for how to manufacture drugs. These records act as guidelines to help manufacturers maintain quality, safety, and reliability of a specific therapy. MBRs also ensure compliance with regulatory bodies.
Equipped with an MBR, operators can repeatedly reproduce products, regardless of who develops them or where. Plus, master batch records are what allows drug manufacturing to happen at scale — all while ensuring safety and efficiency. This is good news for the millions of people worldwide who rely on medications to manage various conditions, including chronic illness and disease.