Document Control:
Document Number: PQ-CM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Cartoning Machine
Objective: To validate the performance of the cartoning machine to ensure it meets the specified requirements for carton packing of solid dosage forms.
Scope: This protocol covers the performance qualification of the cartoning machine located in the packaging/secondary area, specifically focusing on its ability to pack cartons for solid dosage forms.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ protocol and results.
- Equipment Owner: Ensure the cartoning machine is maintained and operational prior to testing.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary documentation including URS Annex11.
- Training of personnel on the cartoning machine operation.
Equipment Description:
The cartoning machine is designed for the automatic packaging of solid dosage forms into cartons. It features leaflet detection, reject logic, and an audit trail for critical processes.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-CM-01 | Verify leaflet detection functionality. | Leaflet detected in 100% of cartons. | Test log and screenshots of detection results. |
| PQ-CM-02 | Audit reject logic speed. | Reject speed ≤ 2 seconds. | Timing records and machine logs. |
| PQ-CM-03 | Review audit trail for completeness. | Audit trail must show all operations. | Audit trail printout and summary report. |
Detailed Test Cases:
- Test Case 1: Execute leaflet detection test. Record the number of cartons with detected leaflets and those without.
- Test Case 2: Measure the time taken for the reject logic to activate upon detection of a missing leaflet.
- Test Case 3: Generate the audit trail report and verify that all actions are logged correctly.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals:
- Validation Team Lead: ______________________
- Quality Assurance: ______________________
- Equipment Owner: ______________________
Data Integrity Checks:
- Ensure all data entries are timestamped and user-identified in the audit trail.
- Perform regular backups of the machine’s data logs to prevent data loss.
- Conduct periodic reviews of the audit trail for anomalies or discrepancies.