Purpose

The purpose of this SOP is to establish the validation requirements for the Dropper/Tip Insertion Machine used in the production of ophthalmic products, ensuring the equipment operates consistently and reliably within specified parameters.

Scope

This procedure applies to the validation of the Dropper/Tip Insertion Machine in the production area for sterile eye drops and ointments. It encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Definitions

• Equipment Validation: The process of ensuring that equipment consistently performs according to its intended use.
• Criticality: The importance of the equipment in relation to product quality and patient safety.
• CSV: Computerized System Validation, necessary for any computerized components of the equipment.

Roles

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

Lifecycle Procedure

1. Design Qualification (DQ): Define user requirements and specifications.
2. Installation Qualification (IQ): Verify the equipment is installed correctly and meets specifications.
3. Operational Qualification (OQ): Test the equipment under normal operating conditions to ensure it functions as intended.
4. Performance Qualification (PQ): Validate the equipment performance with actual product to confirm it meets quality standards.

Good Documentation Practices (GDP) Controls

All validation activities must be documented in accordance with GDP, ensuring that records are complete, accurate, and traceable.

Acceptance Criteria Governance

Acceptance criteria will be established based on User Requirements Specification (URS) and Annex 11 of the relevant guidelines. All results must meet these criteria to consider the validation successful.

Calibration/PM Governance

Regular calibration and preventive maintenance (PM) must be performed as per the manufacturer’s recommendations and internal procedures to ensure ongoing compliance and performance.

Change Control Triggers

Any changes to the equipment, processes, or operating procedures that may affect the validation status must trigger a change control process to assess the impact on validation.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or when significant changes occur. A periodic review should be conducted to ensure the equipment remains compliant with current standards.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Change Control Documents
• Training Records