Master Batch Record (MBR) means a document defining manufacturing methods, materials and other procedures, guidelines and controls related to product manufacturing and testing, also referred to as a manufacturing template. MBR is an integral part of GMP – Good Manufacturing Practice.
The Master Batch Record is designed to ensure that all proper ingredients are added and that each step in the process is completed and documented.
Master Batch Records MBR (called Master Production Records MPR or Master Manufacturing Formulas MMF) are detailed manufacturing instructions. Each unique recipe and batch size must have its own MBR.
The master batch record should require the following information, for example:
- Product name identification.
- A bill of materials detailing the weight, measure, or number of each ingredient needed to make the batch.
- A list of equipment.
- A list of components.
- A statement of theoretical yield at each stage of the manufacturing process.
- The expected yield of the finished product.
- Detailed instructions for each condition in the manufacturing process.
- Sampling and testing procedures.
- Instructions for manual operations.
These documented instructions are required for each unique recipe and batch size to ensure standardization and repeatability of the process every time. Because the MBR is the original template from which copies are taken, it is not filled out during the manufacturing process. It is associated with a production number or part number, but is not associated with any specific lot number.
