Glossary

Master Batch Record (MBR)

What is MBR?

A master batch record (MBR), also known as a master production record (MPR), is a document that contains the approved formulation and instructions guiding the production of a pharmaceutical product.

How does MBR help in pharma?

Master Batch Record (MBR) ensures consistency and accuracy in manufacturing processes. It provides a step-by-step guide for batch production, reducing errors and variability. MBR helps maintain product quality and purity by outlining critical process parameters and controls. It facilitates batch-to-batch reproducibility, ensuring that each batch meets quality and regulatory standards. MBR also serves as a reference document for investigations, audits, and regulatory inspections. By using MBR, pharmaceutical companies can ensure compliance with Good Manufacturing Practices (GMPs) and regulatory requirements.

What are the key regulatory factors for MBR?

The Master Batch Record (MBR) is a critical tool in achieving regulatory compliance within the pharmaceutical industry. It is an approved document outlining the process for manufacturing each product. By clearly defining the necessary ingredients, procedures, and quality control measures, an MBR ensures that each batch of a drug is produced consistently and in accordance with the defined specifications.

Furthermore, as an MBR provides a comprehensive chronicle of the production process, it is an invaluable resource during audits and inspections, enabling manufacturers to demonstrate their adherence to regulatory requirements.

What's the difference between MBR and EBR?

EBRs thrive at efficiency, with automated procedures, real-time data capturing, and optimized workflows that reduce cycle time and increase productivity.

MBRs, which are often paper-based systems, face issues such as version control, data integrity, and accessibility, resulting in inefficiencies and compliance problems.

Compliance: Compliance is the primary objective of both the Master Batch Record (MBR) and the Electronic Batch Record (EBR). However, EBRs are more effective at achieving compliance due to their enhanced capabilities in version control, audit trails, and data integrity.
Flexibility: Some manufacturers find MBRs familiar and adaptable, while others find EBRs generally dynamic and scalable, especially when addressing changing market needs and regulatory requirements.