SOP for Preparation of Lyophilized Formulations for Ophthalmic Use

Standard Operating Procedure for Preparation of Lyophilized Formulations for Ophthalmic Use

1) Purpose

This SOP outlines the procedure for preparing lyophilized formulations intended for ophthalmic use, ensuring product sterility, stability, and compatibility with the ocular environment.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized ophthalmic products.

3) Responsibilities

Formulation Scientists: Responsible for developing formulations that are safe and effective for ocular administration.
Operators: Responsible for preparing the formulation as outlined in the Batch Manufacturing Record (BMR).
QA: Responsible for verifying sterility and proper documentation of the ophthalmic product.

4) Procedure

4.1 Formulation Development

4.1.1 Criteria for Ophthalmic Formulations

4.1.1.1 The formulation should be isotonic with tears and pH-adjusted for compatibility with the eye.
4.1.1.2 Common excipients include stabilizers, buffering agents, and preservatives compatible with ocular tissues.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Weigh the required ingredients as per the BMR.
4.2.1.2 Dissolve the ingredients in a suitable buffer solution and stir until fully dissolved.

4.2.2 Sterile Filtration and Filling

4.2.2.1 Filter the solution through a sterile 0.22-micron filter to ensure sterility.
4.2.2.2 Aseptically fill the sterile ophthalmic containers and freeze before lyophilization.

4.3 Lyophilization and Reconstitution

4.3.1 Transfer the containers to the lyophilizer and follow the lyophilization

cycle as specified in the BMR.

4.3.2 After lyophilization, test reconstitution with a sterile solvent to ensure product integrity and ease of reconstitution.

4.4 Documentation

Record all steps in the Ophthalmic Lyophilized Formulation Logbook, including preparation, sterilization, and lyophilization parameters, and ensure QA verification.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Ophthalmic Lyophilized Formulation Logbook

7) References

Pharmacopoeial guidelines for ophthalmic drug formulations

8) SOP Version

Version 1.0

Annexure

Ophthalmic Lyophilized Formulation Logbook Template


  
    Date
    Formulation Name
    Batch No.
    Sterility Results
    Reconstitution Results
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Formulation Name
    Batch Number
    Sterility Pass/Fail
    Pass/Fail
    Operator Name
    QA Initials

Date	Formulation Name	Batch No.	Sterility Results	Reconstitution Results	Operator Initials	QA Verification
DD/MM/YYYY	Formulation Name	Batch Number	Sterility Pass/Fail	Pass/Fail	Operator Name	QA Initials