Performance Qualification Protocol for the Cartridge Stoppering Machine
Document Control:
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective: To validate the performance of the Cartridge Stoppering Machine to ensure it consistently meets the defined requirements for stopper placement in prefilled syringes and cartridges.
Scope: This protocol applies to the Cartridge Stoppering Machine used in the production area for the insertion of stoppers into cartridges, directly impacting product quality.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Operate the equipment as per the defined procedures.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training for personnel on the operation of the Cartridge Stoppering Machine.
- Availability of necessary materials and equipment for testing.
Equipment Description: The Cartridge Stoppering Machine is designed to insert stoppers into cartridges with precision and reliability. It features an integrated reject logic audit trail for monitoring stopper placement accuracy, ensuring compliance with regulatory standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify stopper placement accuracy. | 100% of stoppers must be placed correctly as per URS Annex 11. | Audit trail logs and visual inspection records. |
| PQ-02 | Check reject logic functionality. | Reject logic must activate for any incorrect placements. | System logs showing reject actions. |
Detailed Test Cases:
- Test Case ID: PQ-01-01
- Procedure: Run the machine with standard cartridges and measure stopper placement.
- Acceptance Criteria: All stoppers placed within specified tolerances.
- Evidence: Data logs and photos of placements.
- Test Case ID: PQ-02-01
- Procedure: Simulate incorrect stopper placement and verify reject logic.
- Acceptance Criteria: Machine must reject improperly placed stoppers.
- Evidence: System logs showing reject events.
Deviations: Any deviations from the acceptance criteria will be documented and investigated. A root cause analysis will be performed to determine corrective actions.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance Manager: _______________ Date: ___________
- Production Supervisor: __________________ Date: ___________
Data Integrity Checks:
- Regular audits of the audit trail logs to ensure no discrepancies.
- Periodic verification of system access logs to prevent unauthorized changes.
- Backup of all data logs to secure locations after each production run.