Description

This document defines the standard procedure for the preparation, review, approval, issuance, and control of the Master Batch Record (MBR) within a pharmaceutical manufacturing facility.

It covers all commercial and clinical trial batches, ensuring that every drug product is manufactured consistently according to Approved Regulatory Dossiers (cGMP, FDA, EMA, and local regulatory guidelines). It spans from the initial drafting stage based on tech transfer/R&D data to final quality assurance approval and subsequent archiving.