Standard Operating Procedure for Sterilization Validation in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a procedure for validating the sterilization processes used in the manufacturing of ocular dosage forms, such as eye drops, ointments, gels, and inserts, to ensure that these processes consistently achieve the desired sterility assurance level (SAL).

2) Scope

This SOP applies to all sterilization processes, including autoclaving, dry heat sterilization, and sterile filtration, used in the production of ocular dosage forms within the pharmaceutical industry.

3) Responsibilities

QA Department: Responsible for approving sterilization validation protocols and reports.
Validation Team: Responsible for planning and executing sterilization validation activities.
Production Department: Responsible for performing sterilization processes according to the validated methods.
Engineering Department: Responsible for maintaining and calibrating sterilization equipment.

4) Procedure

4.1 Preparation

1. Identify critical sterilization process parameters (CSPs) and critical quality attributes (CQAs).
2. Develop a sterilization validation protocol, including objectives, acceptance criteria, sampling plans, and analytical methods.
3. Ensure all sterilization equipment is calibrated and maintained according to SOPs.

4.2 Execution

1. Conduct sterilization validation runs using representative product loads.
2. Monitor and document sterilization process parameters during each validation run.
3. Collect samples of sterilized products at predefined stages for microbiological and physical testing.

4.3 Analysis

1. Analyze samples using validated microbiological and physical methods to assess sterilization efficacy.
2. Compare results against predefined acceptance criteria, including SAL.

4.4 Documentation

1. Document all data, observations, and results in the sterilization validation report.
2. Review and approve the sterilization validation report.

4.5 Approval

1. Submit the sterilization validation report to QA for approval.
2. Obtain final approval before commencing routine sterilization processes.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
CSPs: Critical Sterilization Process Parameters
CQAs: Critical Quality Attributes
SAL: Sterility Assurance Level

6) Documents, if any

1. Sterilization Validation Protocols
2. Sterilization Validation Reports
3. Microbiological Testing Records
4. Physical Testing Records
5. Sterilization Equipment Calibration Records

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
International Conference on Harmonization (ICH) guidelines
FDA Sterilization Process Validation guidelines

8) SOP Version

Version 1.0