Document Control
Document Number: DQ-OPH-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Ophthalmic Filling Machine
Meta Description: This document outlines the Design Qualification Protocol for the Ophthalmic Filling Machine used in the aseptic filling of sterile eye drops, ensuring compliance with URS Annex1 and Annex11 standards.
Objective
The objective of this Design Qualification (DQ) Protocol is to verify that the Ophthalmic Filling Machine is designed to meet the requirements for aseptic filling of eye drops, ensuring product quality and compliance with regulatory standards.
Scope
This protocol applies to the Design Qualification of the Ophthalmic Filling Machine utilized in the production area for sterile eye drops and eye ointments. It encompasses all aspects of the equipment’s design, functionality, and compliance with critical parameters.
Responsibilities
- Validation Team: Responsible for executing and documenting the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ documentation.
- Production Team: Responsible for providing operational insights and supporting validation activities.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) documentation for the equipment.
- Availability of necessary personnel and resources for testing.
Equipment Description
The Ophthalmic Filling Machine is designed for the aseptic filling of sterile eye drops into dropper bottles. It features automated fill volume control, reject logic, and an audit trail for compliance with regulatory requirements.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T01 | Verify fill volume accuracy | Fill volume within ±5% of target | Calibration records, test results |
| T02 | Test reject logic function | Reject logic activates on out-of-spec fill | Test results, system logs |
| T03 | Audit trail verification | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases
Test Case T01: Verify Fill Volume Accuracy
Procedure: Conduct filling tests with calibrated weights and measure the volume filled in each dropper bottle.
Acceptance Criteria: The fill volume must be within ±5% of the target volume.
Evidence: Record all measurements and compare against target; document results.
Test Case T02: Test Reject Logic Function
Procedure: Simulate conditions that would lead to out-of-spec fill volume and observe the reject logic response.
Acceptance Criteria: The system must reject any bottles that do not meet the fill volume criteria.
Evidence: Document instances of rejection and system alerts.
Test Case T03: Audit Trail Verification
Procedure: Review the audit trail generated during filling operations to ensure compliance.
Acceptance Criteria: The audit trail must be complete, with no gaps in data.
Evidence: Generate and review audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be proposed and implemented as necessary.
Approvals
Document approval is required from the Quality Assurance and Validation teams before the equipment can be utilized for production.