Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Stoppering Machine in IV Infusions Production
Objective: To ensure the Stoppering Machine used for IV Infusions meets the required specifications and operates effectively within defined parameters.
Scope: This protocol applies to the validation of the Stoppering Machine in the Production area for placing stoppers on IV infusion bags and bottles.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the validation documentation.
- Production Team: Responsible for operating the Stoppering Machine as per standard operating procedures.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) completed and approved.
- Training of personnel on the operation of the Stoppering Machine.
Equipment Description: The Stoppering Machine is designed to place stoppers on IV infusion bags and bottles with a focus on maintaining placement accuracy. It is critical for ensuring product integrity and compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify placement accuracy of stoppers. | Placement accuracy within ±0.5 mm. | Measurement records. |
| DQ-001-02 | Check reject logic functionality. | Reject logic activates for incorrect placements. | Test run results. |
| DQ-001-03 | Audit trail verification. | Audit trail logs all machine operations. | Audit trail report. |
Detailed Test Cases:
- Test ID DQ-001-01: Measure and record the placement accuracy of stoppers on 10 samples. Acceptable range is ±0.5 mm from the specified target. Document results.
- Test ID DQ-001-02: Simulate incorrect placements and verify that the reject logic activates. Document the number of successful and rejected placements.
- Test ID DQ-001-03: Review the audit trail for completeness, ensuring that all operations are logged. Document any discrepancies found.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: ________________ Date: ___________