Purpose

This Standard Operating Procedure (SOP) provides a framework for the validation of SIP Systems utilized in the production and sterilization of ophthalmic products, ensuring compliance with regulatory requirements and maintaining product integrity.

Scope

This SOP applies to all SIP Systems (Tanks/Lines) used in the production and sterilization of sterile eye drops and eye ointments within the production area.

Definitions

• SIP System: Sterilization In Place System used for sterilizing vessels and lines.
• Validation: A documented process of demonstrating that a procedure, process, or activity will consistently lead to the expected results.
• Criticality: The importance of the equipment in affecting product quality.

Roles

• Validation Team: Responsible for executing validation protocols and documenting results.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Production Personnel: Operate the SIP system and provide necessary operational data.

Lifecycle Procedure

1. Design Qualification (DQ): Assess the design of the SIP system against user requirements.
2. Installation Qualification (IQ): Verify that the system is installed according to specifications.
3. Operational Qualification (OQ): Confirm that the system operates as intended across all anticipated operating ranges.
4. Performance Qualification (PQ): Validate the system’s performance under actual production conditions.

Good Documentation Practices (GDP) Controls

All validation documentation must be completed in accordance with GDP guidelines, ensuring accuracy, legibility, and traceability of records.

Acceptance Criteria Governance

Acceptance criteria shall be established based on User Requirements Specification (URS) and aligned with Annex 15 guidelines to ensure compliance and product quality.

Calibration and Preventive Maintenance (PM) Governance

Calibration and PM of the SIP system must be performed at defined intervals according to the manufacturer’s recommendations and documented in the maintenance log.

Change Control Triggers

Any changes to the SIP system, including modifications, upgrades, or changes in operating procedures, shall initiate a change control process and may require revalidation.

Revalidation Triggers and Periodic Review

Revalidation of the SIP system is required every 12 months or whenever significant changes occur, including but not limited to process changes or equipment modifications.

Records and Attachments List

• Validation Protocols
• Validation Reports
• Calibration Records
• Maintenance Logs
• Change Control Documentation