Purpose

This SOP provides a framework for the validation of the Ophthalmic Sterile Filtration Skid to ensure that it meets the required standards for sterilizing filtration in the production of sterile eye drops and ointments.

Scope

This procedure applies to the validation of the Ophthalmic Sterile Filtration Skid used in the production area for sterilizing filtration processes that impact product quality directly.

Definitions

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• CSV: Computer System Validation
• URS: User Requirements Specification

Roles

The following roles are involved in the validation process:

• Validation Team: Responsible for executing the validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews documentation.
• Production Team: Operates the equipment and provides input on operational requirements.

Lifecycle Procedure

1. Conduct Design Qualification (DQ) to verify user requirements.
2. Perform Installation Qualification (IQ) to ensure proper installation.
3. Complete Operational Qualification (OQ) to validate operational parameters.
4. Execute Performance Qualification (PQ) to confirm performance under actual conditions.

GDP Controls

Good Documentation Practices (GDP) must be adhered to throughout the validation process, ensuring all records are accurate, complete, and traceable.

Acceptance Criteria Governance

Acceptance criteria will be based on URS, Annex 1, and Annex 11 standards to ensure compliance and product quality.

Calibration/PM Governance

Regular calibration and preventive maintenance must be scheduled and documented to ensure equipment reliability and performance.

Change Control Triggers

Change control must be initiated for any modifications to the equipment, process, or associated documentation that may impact validation status.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or when significant changes occur that could impact the validation status.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration Records
• Change Control Documentation
• Periodic Review Records