Master Batch Record (MBR)

Definition

A Master Batch Record is the approved, controlled template that defines the standard procedure, formula, specifications, and step-by-step instructions for manufacturing a specific product. Every Batch Production Record generated for an actual production run is derived from, and must align with, the current approved MBR.

Benefits

Managing the MBR electronically, with strict version control, ensures that only the current approved version can be used to generate a new batch record — eliminating the risk, common in paper environments, of an outdated MBR version being mistakenly used for production.

Use Case

A formulation change requires an MBR revision. Once the updated MBR is approved through the EBR system's change control workflow, it automatically becomes the only version available for new batches, while all previously completed batch records remain permanently linked to the MBR version that was active when they were produced.

Frequently Asked Questions (FAQ)

Related Terms

• Batch Production Record (BPR)
• Version Control
• Bill of Materials (BOM)