Document Control:
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Performance Qualification Protocol for Sterile Powder Filling Machine
Objective: To validate the performance of the Sterile Powder Filling Machine to ensure it meets the specified requirements for filling sterile solutions into vials prior to lyophilization.
Scope: This protocol applies to the Sterile Powder Filling Machine used in the production area for filling sterile solutions into vials, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Operations: Responsible for ensuring the equipment is maintained and operated according to SOPs.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Sterile Powder Filling Machine.
- Availability of necessary documentation, including User Requirement Specification (URS), Standard Operating Procedures (SOPs), and maintenance records.
Equipment Description:
The Sterile Powder Filling Machine is designed to fill sterile solutions into vials prior to lyophilization. It features advanced fill accuracy reject logic and an audit trail for compliance with regulatory standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify fill accuracy using calibrated weights. | Fill accuracy within ± 5% of target volume. | Calibration certificates and weight records. |
| PQ-002 | Audit trail review for fill logic. | Audit trail shows no discrepancies. | Audit trail report. |
Detailed Test Cases:
- Test Case 1: Conduct a fill accuracy test by filling vials with a known volume of sterile solution. Weigh each vial and record the results.
- Test Case 2: Perform an audit trail check by reviewing the system logs for any errors or discrepancies during the filling process.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals:
- ____________________ Prepared By
- ____________________ Approved By
Data Integrity Checks: Since CSV is required, the following data integrity checks will be performed:
- Validation of user access controls to ensure only authorized personnel can modify data.
- Regular backups of audit trails and filling data to prevent data loss.
- Periodic review of system logs to detect any unauthorized access or changes.