Master batch record (MBR)

What is a master batch record (MBR)?

A master batch record (MBR) contains the instructions, recipe or formula, and specific manufacturing process for a particular product. Also known as a master production record (MPR) or master manufacturing formula (MMF), an MBR is required in some industries – most notably, pharmaceuticals – by regulatory bodies or industry advisory groups. The U.S. Food and Drug Administration (FDA), for example, requires manufacturers that fall under its jurisdiction to create and maintain an MBR for each product formulation/recipe and batch size.

Master batch records are intended to ensure that manufacturers use the right ingredients and the right processes in the right sequence to make the product as it is designed. The key result is that product characteristics and performance are the same from batch to batch.

Historically, the master batch record was generated and maintained on paper. Numerous benefits are gained by using MBR software to create and manage an electronic master batch record: accessibility, easier version control, opportunities to enforce compliance, fewer errors, and greater efficiency, to name a few. Master batch record software is part of a manufacturing execution system (MES) and is seamlessly integrated with MES workflow management. This integration streamlines batch production operations.

The master batch record is created by the appropriate technical staff. MBR software enables these individuals to efficiently design, execute, review and release the master batch record for each product and batch size.

As the name suggests, the master batch record (or master production record or master manufacturing formula) lays out the planned manufacture of a product. For each batch that follows the MBR, an electronic batch record (eBR) is produced. What the MBR lays out is what is expected to happen; the eBR documents what actually happened in the production of an individual batch – what material lot, specific equipment, and operators were involved; duration of each step; sample and test results; and so on.

Image of pharmaceuticals being manufacturing according to the master batch record (mbr)

Elements of a master batch record (MBR)

To ensure sufficient information is available to maintain product consistency from batch to batch, the master batch record should include the following pieces of information:

  • Product name and reference code (if one exists)

  • Patent number (if one exists)

  • Product properties and characteristics

  • Product formula or composition

  • Batch size

  • Bill of materials

  • Bill of process

  • Expected yield after each process step

  • Acceptable machinery to be used and its location

  • Work instructions for each station/stage of production

  • Quality procedures, including sampling, testing, and acceptable results

  • Required packaging and storage conditions

  • Special safety requirements

Benefits of MBR software

MBR software provides electronic management of master batch records. It expedites the design, execution, review and release of match batch records and connects them electronically to each eBR.

Additional benefits:

  • Flexibility in the MBR design process

  • Version control

  • Faster information exchange and retrieval

  • Fewer human errors