Standard Operating Procedure for Buffer Preparation for Lyophilized Formulations

1) Purpose

This SOP outlines the steps for preparing buffers used in lyophilized formulations, ensuring the correct pH and composition to maintain the stability of active ingredients during lyophilization.

2) Scope

This SOP applies to all personnel involved in the preparation of buffers for lyophilized products, including production and quality teams.

3) Responsibilities

• Production Operators: Responsible for preparing the buffers according to the batch manufacturing record (BMR).
• QA: Responsible for verifying buffer composition and pH.

4) Procedure

4.1 Buffer Preparation

4.1.1 Raw Materials and Equipment

• 4.1.1.1 Ensure all raw materials for buffer preparation meet the specifications provided in the BMR.
• 4.1.1.2 Calibrate pH meters and other equipment.

4.1.2 Mixing Procedure

• 4.1.2.1 Measure out the required quantities of buffer components using calibrated equipment.
• 4.1.2.2 Add the components to deionized water and stir until dissolved.
• 4.1.2.3 Adjust the pH as required using acid or base solutions.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Buffer Preparation Logbook

7) References

• Buffer preparation standards in pharmacopeia

8) SOP Version

Version 1.0

Annexure

Buffer Preparation Logbook Template

  

    
Date
    
Buffer Name
    
Batch No.
    
pH
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Buffer Name
    
Batch Number
    
pH Value
    
Operator Name
    
QA Initials