Document Control Number: PQ-OCV-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Review Date]
Performance Qualification Protocol for Ophthalmic Compounding Vessel
Objective: To validate the performance of the Ophthalmic Compounding Vessel to ensure it meets the specified requirements for the preparation of sterile ophthalmic bulk solutions and ointment bases.
Scope: This protocol applies to the Ophthalmic Compounding Vessel used in the production area for ophthalmic products. It encompasses the validation of critical parameters affecting product quality.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Production Team: Ensures the equipment is set up and maintained according to SOPs.
- Quality Assurance: Reviews and approves the PQ protocol and results.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel involved in the PQ process.
Equipment Description:
The Ophthalmic Compounding Vessel is a jacketed stainless steel vessel designed for the preparation of sterile ophthalmic solutions and ointments. It features controlled agitation, temperature regulation, and a PLC audit trail for data integrity.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001 | Verify agitation speed and consistency. | Agitation speed within ±10% of set point. | Agitation log records. |
| PQ-002 | Perform temperature hold time check. | Temperature maintained within specified range for duration. | Temperature monitoring logs. |
| PQ-003 | Review PLC audit trail for data integrity. | No discrepancies in recorded data. | Audit trail report. |
Detailed Test Cases:
- Test ID: PQ-001
- Procedure: Set the agitation speed to the defined set point and monitor for consistency over a 30-minute period.
- Acceptance: Agitation speed must remain within ±10% of the set point.
- Evidence: Agitation log records will be reviewed and attached to the final report.
- Test ID: PQ-002
- Procedure: Set the vessel to the required temperature and maintain for the specified hold time.
- Acceptance: Temperature must be maintained within the specified range for the entire duration.
- Evidence: Temperature monitoring logs will be reviewed and attached to the final report.
- Test ID: PQ-003
- Procedure: Access the PLC audit trail and review for any discrepancies during the test period.
- Acceptance: No discrepancies should be present in the recorded data.
- Evidence: The audit trail report will be reviewed and attached to the final report.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A root cause analysis may be required for critical deviations.
Approvals:
- Validation Team Lead: ______________________ Date: ____________
- Quality Assurance: ______________________ Date: ____________
- Production Manager: ______________________ Date: ____________