What is batch manufacturing record
A batch manufacturing record (BMR) is a document that provides a detailed, sequential account of the manufacturing process for a specific batch of pharmaceuticals, biologics, or medical devices. It is a critical document that ensures the quality and integrity of the manufacturing process, as well as compliance with regulatory requirements.
A typical BMR includes information such as:
- Batch number and product description
- Manufacturing formula and processing instructions
- Raw material specifications and testing results
- Equipment used and maintenance records
- Manufacturing steps, including dates and times
- In-process testing and inspection results
- Packaging and labeling information
- Batch release and certification
The purpose of a BMR is to provide a clear and transparent record of the manufacturing process, allowing for traceability and accountability. This ensures that the manufactured product meets the required quality and purity standards, and that any deviations or issues can be identified and addressed promptly.
In the pharmaceutical industry, BMRs are subject to strict regulatory guidelines, such as those outlined by the US FDA's Code of Federal Regulations (CFR) Title 21, Part 211.
Recommended products/services that can help with batch manufacturing record management include:
- MasterControl's Manufacturing Excellence solution for automated batch record management
- SAP's Pharma and Life Sciences solution for batch manufacturing and quality management
- TrackWise's Quality Management System for batch record management and compliance