Equipment Validation SOP for Manual Inspection Booth in Ophthalmics

Purpose: This SOP outlines the validation process for the Manual Inspection Booth used in the production of sterile eye drops and eye ointments, ensuring compliance with regulatory standards and quality assurance.

Scope: This procedure applies to the Manual Inspection Booth utilized in the production area for manual inspection of ophthalmic products. It covers the entire lifecycle from Design Qualification (DQ) through Performance Qualification (PQ).

Definitions:

• Equipment: Manual Inspection Booth (Controlled Lux)
• Criticality: Major
• Product Impact: Direct
• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification

Roles:

• Validation Team: Responsible for executing and documenting validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Production Personnel: Operate the equipment and provide feedback on its functionality.

Lifecycle Procedure:

1. Design Qualification (DQ): Ensure equipment design meets user requirements and specifications.
2. Installation Qualification (IQ): Verify equipment installation per manufacturer specifications.
3. Operational Qualification (OQ): Test equipment operations under normal and worst-case scenarios.
4. Performance Qualification (PQ): Validate the equipment’s performance in the production environment.

GDP Controls: Good Documentation Practices must be followed during all validation activities to ensure traceability and compliance.

Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirement Specifications (URS) and must be met for each qualification phase.

Calibration/PM Governance: The Manual Inspection Booth must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies.

Change Control Triggers: Any changes to the equipment, its operating procedures, or the production environment will trigger a change control process, requiring re-evaluation of the validation status.

Revalidation Triggers and Periodic Review: Revalidation will occur every 12 months or whenever significant changes are made to the equipment or process. A periodic review will assess the continued compliance and performance of the equipment.

Records/Attachments List:

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