Document Control
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Operational Qualification Protocol for Aseptic Filling Machine in NDDS Production
Objective: To validate the operational performance of the Aseptic Filling Machine used for the aseptic filling of NDDS products, ensuring compliance with regulatory requirements and acceptance criteria.
Scope: This protocol applies to the Aseptic Filling Machine utilized in the production area for the aseptic filling of liposomes and lipid nanoparticles (LNP) in vials, pre-filled syringes (PFS), and cartridges.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary access and support during testing.
Prerequisites:
Ensure the Aseptic Filling Machine is installed, calibrated, and maintained according to the manufacturer’s specifications and company SOPs. All personnel involved in the qualification must be trained in aseptic techniques and validation procedures.
Equipment Description:
The Aseptic Filling Machine is designed for the aseptic filling of NDDS products into vials, PFS, and cartridges. It features fill accuracy controls, aseptic controls, reject logic, and an audit trail for documentation.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify fill accuracy using calibrated weight measures. | Fill accuracy within ±5% of target volume. | Calibration certificates, weight logs. |
| OQ-02 | Test aseptic controls by performing media fills. | No contamination observed post incubation. | Media fill results, incubation logs. |
| OQ-03 | Validate reject logic functionality. | All rejects logged appropriately. | Log files, system audit reports. |
| OQ-04 | Audit trail verification. | All actions recorded with timestamps and user IDs. | Audit trail reports. |
Detailed Test Cases:
Test Case OQ-01: Verify fill accuracy.
Procedure: Measure the fill volume of 10 vials and calculate the average fill volume. Compare against target volume.
Acceptance Criteria: Fill accuracy within ±5% of target volume.
Evidence: Documented weight measurements and calculations.
Test Case OQ-02: Media fill testing.
Procedure: Perform media fill according to SOP, incubate for 14 days, and assess for contamination.
Acceptance Criteria: No contamination observed.
Evidence: Media fill report and incubation records.
Test Case OQ-03: Reject logic validation.
Procedure: Simulate a filling error and ensure the system rejects the fill.
Acceptance Criteria: All rejects are logged and documented.
Evidence: System logs and reports.
Test Case OQ-04: Audit trail verification.
Procedure: Review the audit trail for completeness and accuracy.
Acceptance Criteria: All actions should be logged with proper user identification.
Evidence: Audit trail report.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis may be required for critical deviations.
Approvals:
Prepared By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________