Document Number: PQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Performance Qualification Protocol for Aseptic Filling of Long-Acting Injectables
Objective: To validate the aseptic filling process for depot suspension products to ensure compliance with regulatory requirements and product specifications.
Scope: This protocol applies to the aseptic filling equipment used for Long-Acting Injectables in the Production area, focusing on the critical parameters impacting product quality.
Responsibilities:
- Validation Team: Overall execution and documentation of the PQ protocol.
- Production Personnel: Ensure equipment is operated per SOPs during testing.
- Quality Assurance: Review and approve all validation documentation.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment.
- Training records for personnel involved in the PQ process.
Equipment Description: The Aseptic Filling system is designed for the sterile filling of depot suspension products into pre-filled syringes (PFS) and vials, ensuring a sterile environment and precise fill accuracy.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-01 | Verify fill accuracy by measuring filled volume. | Volume within ±5% of target fill volume. | Calibration records and measurement logs. |
| PQ-001-02 | Assess suspension homogeneity using visual inspection. | No phase separation or sedimentation observed. | Photographic evidence and inspection logs. |
| PQ-001-03 | Evaluate aseptic controls through environmental monitoring. | Microbial counts within acceptable limits. | Environmental monitoring reports. |
| PQ-001-04 | Review audit trail for data integrity checks. | All entries logged with timestamps and user IDs. | Audit trail reports. |
Detailed Test Cases:
- Test Case 1: Measure the filled volume of 10 syringes and calculate the average fill volume.
- Test Case 2: Perform a visual inspection of 10 vials for any signs of phase separation.
- Test Case 3: Conduct environmental monitoring during a filling run; record and analyze results.
- Test Case 4: Generate and review the audit trail for the filling process to ensure compliance with data integrity standards.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A deviation report will be generated for all critical failures.
Approvals:
- Validation Manager: ________________________ Date: __________
- Quality Assurance: ________________________ Date: __________