Document Control Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Ophthalmic Filling Machine
This document outlines the Performance Qualification (PQ) protocol for the Ophthalmic Filling Machine used in the aseptic filling of eye drops.
Objective: To validate the performance of the Ophthalmic Filling Machine to ensure compliance with regulatory requirements and product specifications.
Scope: This protocol applies to the Performance Qualification of the Ophthalmic Filling Machine used in the production of sterile eye drops in the production area.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ protocol and results.
- Production Team: Ensure equipment is set up and maintained according to SOPs.
Prerequisites:
- Installation Qualification (IQ) and Operational Qualification (OQ) must be completed and approved.
- Personnel must be trained on the equipment and procedures.
Equipment Description:
The Ophthalmic Filling Machine is designed for the aseptic filling of eye drops into dropper bottles. Key features include:
- Automated filling process
- Fill volume accuracy
- Reject logic for non-conforming products
- Audit trail capabilities
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify fill volume accuracy | Fill volume within ± 5% of target | Calibration report, filled samples |
| PQ-02 | Audit reject logic | Reject logic functions correctly | Test results, system logs |
| PQ-03 | Verify audit trail | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases:
- Test ID: PQ-01
- Procedure: Measure the fill volume of 10 samples and calculate the average.
- Acceptance Criteria: The average fill volume must be within ± 5% of the target volume.
- Evidence: Record of measurements and calculations.
- Test ID: PQ-02
- Procedure: Simulate a non-conforming product and verify the reject logic.
- Acceptance Criteria: The machine must reject the non-conforming product.
- Evidence: System logs and observations.
- Test ID: PQ-03
- Procedure: Review the audit trail for completeness and accuracy.
- Acceptance Criteria: The audit trail must capture all relevant actions.
- Evidence: Audit trail report.
Deviations: Any deviations from the protocol must be documented and justified. Approvals for deviations must be obtained from the Quality Assurance department.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance: ___________________ Date: ___________
Data Integrity Checks: Ensure that all data recorded during the PQ is backed up, and access to the system is controlled to maintain data integrity.