📘 SOP : Change Control Management for Batch Records
1. 🎯 Purpose To establish a robust, traceable, and regulatory-compliant system for managing changes in Master Batch Records (MBR), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR) to ensure: This SOP ensures that no unauthorized or undocumented change impacts manufacturing or documentation processes. 2. 🌍 Scope This SOP applies to: Applicable to departments: 3. […]
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