Document Control
Protocol Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Performance Qualification Protocol for Cartridge Filling Machine
Objective: To validate the performance of the Cartridge Filling Machine to ensure it fills sterile drug into cartridges accurately and consistently, adhering to regulatory standards.
Scope: This protocol applies to the Cartridge Filling Machine used in the production area for filling prefilled syringes and cartridges with sterile drug products.
Responsibilities:
- Validation Team: Execute and document the PQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide support and access to the equipment.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment.
- Training of personnel on the use of the Cartridge Filling Machine.
Equipment Description: The Cartridge Filling Machine is designed to fill sterile drug solutions into cartridges with precise fill volume and minimal contamination risk. It features automated fill accuracy reject logic and maintains audit trail logs for data integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Perform fill accuracy test using calibrated weight method. | Fill volume within ± 5% of target. | Calibration certificate, weight logs. |
| PQ-02 | Verify reject logic functionality. | Reject logic triggers on out-of-spec fills. | System logs, audit trail reports. |
| PQ-03 | Check audit trail logs for data integrity. | All actions logged with timestamps and user IDs. | Audit trail report. |
Detailed Test Cases
Test ID: PQ-01
Procedure: Conduct fill accuracy test by filling a series of cartridges and weighing them to determine fill volume.
Expected Outcome: All filled cartridges should meet the acceptance criteria of ± 5% of the target fill volume.
Test ID: PQ-02
Procedure: Simulate out-of-spec fills and verify that the reject logic functions correctly to prevent these from being processed.
Expected Outcome: System should reject any out-of-spec fills and log the event appropriately.
Test ID: PQ-03
Procedure: Review the audit trail logs to ensure all actions are recorded accurately.
Expected Outcome: Audit trail should show complete and accurate records of all operations performed.
Deviations
Any deviations from the protocol must be documented and approved by the Quality Assurance team. Justification for the deviation should be provided and assessed for impact on product quality.
Approvals
Prepared By: [Insert Name]
Date: [Insert Date]
Approved By: [Insert Name]
Date: [Insert Date]
Data Integrity Checks
During the PQ stage, the following data integrity checks will be performed:
- Verification of user access controls to ensure only authorized personnel can operate the machine.
- Regular review of audit trail logs to confirm that all actions are recorded and can be traced back to specific operators.
- Routine checks of system backups to prevent data loss.