PREPARATION, APPROVAL, AND REVISION OF MASTER FORMULA RECORD

Description

A Master Formula Record (MFR) is a comprehensive document that details the complete manufacturing process of a pharmaceutical product. It serves as a master blueprint, providing essential information to ensure consistent and accurate production of each batch.  

• Product details: Name, dosage form, strength, specifications.  
• Formula: Quantities and sources of raw materials.
• Manufacturing process: Step-by-step instructions, including equipment, parameters, and quality checks.  
• Packing procedure: Details of packaging materials and operations.  
• Quality control: Specifications for in-process and final product testing.  
• Yield: Expected and acceptable yield calculations.  
  MFRs are vital for regulatory compliance, quality assurance, and effective manufacturing operations within the pharmaceutical industry.