Document Control
Document ID: DQ-CT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for Cooling Tunnel in Suppository Production
Objective: To ensure the Cooling Tunnel used for cooling suppositories after molding meets all operational and regulatory requirements.
Scope: This protocol applies to the Cooling Tunnel located in the Production area for the cooling of suppositories and implants. The validation will confirm that the equipment operates within specified parameters and complies with URS Annex11 acceptance criteria.
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 Cooling Tunnel according to SOPs.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of necessary documentation, including URS and SOPs.
- Training of personnel on the operation of the Cooling Tunnel.
Equipment Description:
The Cooling Tunnel is designed to cool suppositories after molding, ensuring that they reach the appropriate temperature for further processing. The critical parameters include cooling temperature, airflow, time, PLC logs, and audit trail capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-CT-001 | Verify cooling temperature during operation. | Temperature must be within specified range (e.g., 5-10°C). | Temperature logs and PLC data. |
| DQ-CT-002 | Check airflow rate. | Airflow must meet specifications (e.g., 200-300 CFM). | Airflow measurement logs. |
| DQ-CT-003 | Monitor cooling time. | Cooling time must not exceed specified duration (e.g., 15 minutes). | Time logs from PLC. |
| DQ-CT-004 | Review PLC logs for accuracy. | Logs must show consistent data without discrepancies. | PLC audit trail report. |
Detailed Test Cases:
- Test Case 1: Execute cooling cycle and record temperature data. Verify against acceptance criteria.
- Test Case 2: Measure airflow using calibrated equipment and compare to specifications.
- Test Case 3: Document cooling time for multiple cycles and ensure compliance with defined limits.
- Test Case 4: Audit PLC logs for data integrity and accuracy.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan will be developed for any non-conformance found during testing.
Approvals:
- Prepared by: ___________________ Date: ___________
- Reviewed by: ___________________ Date: ___________
- Approved by: ___________________ Date: ___________
Data Integrity Checks:
- Regular audits of PLC logs to ensure data accuracy.
- Cross-verification of manual logs with automated data.
- Implementation of alerts for out-of-spec conditions.