Document Control:
Document Number: PQ-CT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Cooling Tunnel in Suppository Production
Objective: To establish a validated process for the cooling of suppositories after molding using the Cooling Tunnel, ensuring compliance with regulatory standards and product quality.
Scope: This protocol applies to the Cooling Tunnel used in the production area for the cooling of suppositories and implants, impacting product quality directly.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ documentation.
- Production Team: Ensure equipment is functioning as per the validated state.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the Cooling Tunnel.
- Availability of necessary materials and equipment for testing.
Equipment Description:
The Cooling Tunnel is designed to cool suppositories post-molding. It utilizes controlled airflow and temperature settings to ensure optimal cooling conditions, with PLC logs providing an audit trail of operational parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-CT-01 | Measure cooling temperature at various points in the tunnel. | Temperature must be within specified limits as per URS Annex 11. | Temperature log records. |
| PQ-CT-02 | Verify airflow rate through the tunnel. | Airflow must meet design specifications. | Airflow measurement records. |
| PQ-CT-03 | Record cooling time for suppositories. | Cooling time must be consistent with process requirements. | Time logs and batch records. |
| PQ-CT-04 | Review PLC logs for audit trail compliance. | Logs must show no discrepancies. | PLC log review documentation. |
Detailed Test Cases:
- Test Case 1: Verify that the cooling temperature is maintained at 10°C ± 2°C throughout the tunnel during operation.
- Test Case 2: Ensure that the airflow rate is consistent with the validated parameters of 200-250 CFM.
- Test Case 3: Confirm that the cooling time for suppositories is no less than 30 minutes.
- Test Case 4: Check the audit trail in the PLC logs for any unauthorized changes or gaps in data.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.
Approvals:
- Prepared by: ______________________
- Reviewed by: ______________________
- Approved by: ______________________
Data Integrity Checks:
- Ensure all data entries in the PLC are time-stamped and cannot be altered without a record.
- Conduct regular audits of the cooling tunnel logs to confirm compliance with established protocols.
- Implement electronic signatures for all data entries by authorized personnel.