Document Control Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Vial Stoppering Machine in Production
Objective: To establish a Design Qualification (DQ) protocol for the Vial Stoppering Machine used in the production of sterile powders and lyophilized products, ensuring compliance with regulatory standards.
Scope: This protocol applies to the Vial Stoppering Machine utilized in the production area for the insertion of stoppers before the lyophilization process.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Review and approval of the DQ protocol and results.
- Production Team: Provide necessary operational support during testing.
Prerequisites:
- Completion of User Requirement Specification (URS) for the Vial Stoppering Machine.
- Installation Qualification (IQ) and Operational Qualification (OQ) protocols completed.
- Personnel trained on the operation of the Vial Stoppering Machine.
Equipment Description:
The Vial Stoppering Machine is designed for the partial stoppering of vials containing sterile powders and lyophilized products. It is equipped with features to ensure accurate stopper placement and includes an audit trail log for monitoring critical parameters.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify stopper placement accuracy through audit trail logs. | 100% accuracy in stopper placement. | Audit trail log report. |
| DQ-001-02 | Check for any deviations noted during operation. | No critical deviations recorded. | Deviation log. |
| DQ-001-03 | Review data integrity checks for CSV compliance. | All data integrity checks passed. | Data integrity check report. |
Detailed Test Cases:
- Test Case DQ-001-01:
Procedure: Conduct an audit trail review of stopper placement accuracy.
Acceptance Criteria: 100% accuracy in stopper placement as per URS Annex11.
Evidence: Generated audit trail log.
- Test Case DQ-001-02:
Procedure: Document any deviations during the operation of the machine.
Acceptance Criteria: No critical deviations recorded.
Evidence: Deviation log maintained during the testing phase.
- Test Case DQ-001-03:
Procedure: Perform data integrity checks relevant to CSV requirements.
Acceptance Criteria: All data integrity checks must pass.
Evidence: Data integrity check report generated.
Deviations: Any deviations from established acceptance criteria must be documented and investigated. A corrective action plan should be initiated for any critical deviations.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: _______________ Date: ___________