Document ID: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Suppository Blister Packing Machine
Objective: To establish and document the qualification of the Suppository Blister Packing Machine to ensure it meets operational requirements and complies with regulatory standards.
Scope: This protocol applies to the qualification of the Suppository Blister Packing Machine used in the packaging area for the direct packing of suppositories into blister packs.
Responsibilities:
- Validation Team: Responsible for executing the qualification protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Operations: Responsible for ensuring the equipment is maintained and operated according to the validated state.
Prerequisites:
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) completed.
- All personnel trained on equipment operation and quality standards.
Equipment Description:
The Suppository Blister Packing Machine is designed to pack suppositories into blister packs efficiently. The equipment operates under controlled conditions, ensuring product integrity and compliance with specifications.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify sealing temperature | Temperature within specified range as per URS Annex 11 | Temperature logs |
| DQ-001-02 | Check sealing pressure | Pressure within specified range as per URS Annex 11 | Pressure logs |
| DQ-001-03 | Evaluate dwell time | Dwell time meets specifications as per URS Annex 11 | Dwell time logs |
| DQ-001-04 | Audit trail verification | Audit trails must be complete and accurate | Audit trail logs |
Detailed Test Cases:
- Sealing Temperature:
Procedure: Set the machine to the specified sealing temperature and record the actual temperature.
Acceptance: The recorded temperature should fall within the limits defined in the URS Annex 11.
Evidence: Printouts from the temperature monitoring system.
- Sealing Pressure:
Procedure: Adjust the sealing pressure and measure the output.
Acceptance: Pressure readings must align with the specifications outlined in the URS Annex 11.
Evidence: Pressure gauge readings documented in the logbook.
- Dwell Time:
Procedure: Measure the time taken for each sealing operation.
Acceptance: Dwell time must meet the parameters specified in the URS Annex 11.
Evidence: Dwell time records from the machine.
- Audit Trail:
Procedure: Review the audit trail for completeness.
Acceptance: All operations must be logged without discrepancies.
Evidence: Audit trail report generated by the machine.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed. Corrective actions should be implemented as necessary.
Approvals:
- Prepared By: ______________________ Date: ____________
- Approved By: ______________________ Date: ____________