Document Control:
Document ID: DQ-OTFM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Ointment Tube Filling Machine
Objective: To establish the design qualification of the Ointment Tube Filling Machine for the production of sterile ophthalmic products, ensuring it meets the required specifications and regulatory standards.
Scope: This protocol applies to the validation of the Ointment Tube Filling Machine used in the production and packaging of sterile eye drops and eye ointments.
Responsibilities:
- Validation Team: Responsible for executing and documenting the qualification activities.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Engineering: Responsible for maintaining the equipment and ensuring compliance with specifications.
Prerequisites:
- Completed User Requirements Specification (URS) for the equipment.
- Installation Qualification (IQ) completed and approved.
- Personnel trained on equipment operation and validation procedures.
Equipment Description:
The Ointment Tube Filling Machine is designed for the sterile filling of ointments into ophthalmic tubes. It operates under controlled conditions to ensure product integrity and compliance with regulatory standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify fill weight | Fill weight within ±5% of target | Calibration records, weight logs |
| T2 | Test sealing integrity | No leaks detected | Seal test results |
| T3 | Audit trail verification | Complete and accurate audit trail | System logs |
Detailed Test Cases:
- Test Case T1: Conduct a fill weight test using calibrated scales. Record weights of filled tubes and compare to target weight.
- Test Case T2: Perform a sealing integrity test on filled tubes using appropriate leak detection methods.
- Test Case T3: Review and verify the audit trail from the machine’s software to ensure all actions are logged and traceable.
Deviations: Any deviations from the acceptance criteria must be documented with an explanation and a corrective action plan.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: _______________ Date: ___________
Data Integrity Checks: Regular checks will be performed to ensure data integrity during the filling process, including verification of data logs and system access controls.