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.
- Discrepancy data
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.
Computerised Master Batch Record
A computerised Master Batch Record is a modernised approach to manufacturing record-keeping, integrating advanced software solutions into the production process. This digital transformation revolutionises how manufacturing operations are managed, providing a comprehensive system for creating, managing, and optimising production workflows.
Key Features and Benefits
- Real-time Data Integration: Digital MBR seamlessly integrates with various manufacturing systems, enabling real-time data exchange. This connectivity ensures that up-to-date information is readily available to manufacturing personnel, enhancing decision-making and issue resolution.
- Error Reduction: Automation within Digital MBR significantly reduces the risk of human error by automating data entry and incorporating validation checks. This results in greater consistency and higher product quality.
- Efficient Recipe Management: Digital MBR simplifies the management of multiple recipes for different products and batch sizes. Manufacturers can create, update, and maintain recipes effortlessly, ensuring accurate production every time.
- Version Control: Robust version control capabilities in DMBR systems guarantee that manufacturing instructions comply with the latest regulations. Manufacturers can adapt swiftly to changing requirements without compromising compliance.
- Electronic Signatures and Audit Trails: Computerised MBR facilitates electronic signatures and maintains comprehensive audit trails. This feature is vital for tracking and authenticating critical actions, aiding regulatory compliance, and supporting investigations.
