Document Number: OQ-PSF-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Prefilled Syringe Filling Machine
Objective: To establish and document the operational qualification of the Prefilled Syringe Filling Machine to ensure it meets specified performance criteria.
Scope: This protocol applies to the Prefilled Syringe Filling Machine used in the production area for filling sterile drugs into syringes.
Responsibilities:
- Validation Team: To execute the protocol and document results.
- Quality Assurance: To review and approve the protocol and results.
- Production Team: To operate the equipment during testing.
Prerequisites:
- Equipment must be installed and calibrated according to manufacturer’s specifications.
- Operators must be trained on equipment operation and safety procedures.
- All necessary materials (syringes, drug product, etc.) must be available.
Equipment Description: The Prefilled Syringe Filling Machine is designed to fill sterile drug formulations into pre-sterilized syringes with a focus on fill accuracy and integrity. The machine includes features for reject logic, audit trail logs, and critical parameter monitoring.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify fill accuracy using calibrated weights. | Fill accuracy must be within ±5% of target volume. | Weight measurement logs, calibration certificates. |
| OQ-002 | Test reject logic functionality. | Reject logic must activate for out-of-spec fills. | Audit trail logs, test results. |
| OQ-003 | Review audit trail logs for integrity. | All entries must be time-stamped and user-identified. | Audit trail log reports. |
Detailed Test Cases:
- Test Case OQ-001: Fill accuracy will be tested by filling syringes with a known volume and weighing them. Results must be documented and compared to acceptance criteria.
- Test Case OQ-002: A series of test fills will be conducted, and the reject logic will be triggered by intentionally filling beyond the acceptance criteria. The system must log this event correctly.
- Test Case OQ-003: A review of the audit trail will be conducted to ensure all entries are secure and meet data integrity standards.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed for any failures.
Approvals:
- Validation Team Lead: ______________________ Date: _____________
- Quality Assurance Manager: ______________________ Date: _____________
Data Integrity Checks: Ensure that all data entered into the system is validated against predefined criteria, and all changes are logged with appropriate user identification and time stamps.