Design Qualification Protocol for Leak Test Machine in Ophthalmics
Document Number: DQ-LEAK-001
Version: 1.0
Effective Date: 2023-10-01
Prepared by: [Name]
Reviewed by: [Name]
Approved by: [Name]
Objective
The objective of this Design Qualification (DQ) protocol is to establish and document the requirements for the Leak Test Machine used in the production of sterile ophthalmic products, ensuring compliance with applicable regulatory and quality standards.
Scope
This protocol applies to the Leak Test Machine utilized for container leak testing in the production and quality control areas of sterile eye drops and eye ointments.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for operating the Leak Test Machine as per the validated procedures.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of the Leak Test Machine in the production area.
- Training of personnel on the operation of the Leak Test Machine.
Equipment Description
The Leak Test Machine is an instrument designed for the sensitive detection of leaks in containers used for sterile ophthalmic products. It operates using pressure decay methods, ensuring accurate and reliable results in compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-TEST-001 | Conduct pressure decay test on empty containers. | Sensitivity pressure decay must be within specified limits (as per URS Annex11). | Test results report, audit trail log. |
| DQ-TEST-002 | Validate audit trail functionality. | Audit trail must capture all relevant data and actions. | Audit trail report. |
Detailed Test Cases
Test Case 1: Sensitivity Pressure Decay
Procedure: Place empty containers in the Leak Test Machine and initiate the pressure decay test.
Acceptance Criteria: The pressure decay must not exceed the limits specified in the URS Annex11.
Evidence: Record the pressure decay values and compare against acceptance criteria.
Test Case 2: Audit Trail Verification
Procedure: Perform a series of tests and ensure the machine records all actions in the audit trail.
Acceptance Criteria: All actions must be recorded with timestamps and user identification.
Evidence: Generate and review the audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be established to address any identified issues.
Approvals
This protocol must be approved by the Validation Manager and Quality Assurance prior to execution.