Standard Operating Procedure for Incorporation of Stabilizers in Lyophilized Formulations

1) Purpose

This SOP outlines the process for selecting and incorporating stabilizers into lyophilized formulations, ensuring product stability during and after lyophilization.

2) Scope

This SOP applies to the formulation team, production operators, and QA staff responsible for the incorporation of stabilizers in lyophilized formulations.

3) Responsibilities

• Formulation Scientists: Responsible for selecting the stabilizer appropriate for the formulation.
• Operators: Responsible for accurately incorporating the stabilizer as per the BMR.
• QA: Responsible for verifying stabilizer addition and related documentation.

4) Procedure

4.1 Selection of Stabilizers

4.1.1 Criteria for Selection

• 4.1.1.1 Stabilizers should protect the API and excipients during the drying process.
• 4.1.1.2 Stabilizers such as sugars (e.g., trehalose, sucrose), amino acids (e.g., glycine), and polymers are commonly used.

4.2 Incorporation of Stabilizers

4.2.1 Weighing and Dispensing

• 4.2.1.1 Weigh the stabilizer as per the formulation guidelines.
• 4.2.1.2 Dispense the stabilizer into the formulation solution before lyophilization.

4.2.2 Mixing

• 4.2.2.1 Ensure the stabilizer is completely dissolved by stirring the solution appropriately.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Stabilizer Addition Logbook

7) References

• Research papers and articles on stabilizers used in lyophilization

8) SOP Version

Version 1.0

Annexure

Stabilizer Addition Logbook Template

  

    
Date
    
Stabilizer Name
    
Batch No.
    
Quantity
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Stabilizer Name
    
Batch Number
    
Quantity in grams
    
Operator Name
    
QA Initials