Performance Qualification Protocol for LVP/SVP Compounding Vessel
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the LVP/SVP Compounding Vessel operates within specified limits to ensure consistent preparation of bulk infusion solutions.
Scope
This protocol applies to the LVP/SVP Compounding Vessel located in the Production area and is intended for use in the preparation of bulk infusion solutions affecting product quality.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for operating the equipment during the qualification process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of qualified personnel for execution.
- Access to relevant Standard Operating Procedures (SOPs).
Equipment Description
The LVP/SVP Compounding Vessel is a jacketed stainless steel vessel designed for the preparation of large volume parenteral (LVP) and small volume parenteral (SVP) infusion solutions. It features integrated agitation and temperature control systems to ensure product quality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify agitation speed and consistency. | Agitation speed within ±10% of set point. | Agitation log report. |
| PQ-002 | Measure temperature during hold time. | Temperature maintained within specified range. | Temperature log report. |
| PQ-003 | Check PLC audit trail for accuracy. | No discrepancies in the audit trail. | PLC audit trail report. |
Detailed Test Cases
Test Case 1: Agitation Verification
Procedure: Start the vessel and record agitation speed. Verify against set point.
Expected Result: Agitation speed should be within ±10% of set point.
Test Case 2: Temperature Monitoring
Procedure: Initiate a hold time and monitor temperature continuously.
Expected Result: Temperature should remain within specified limits throughout the hold time.
Test Case 3: PLC Audit Trail Review
Procedure: Extract and review PLC audit trail data.
Expected Result: Audit trail should show no discrepancies during the qualification process.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be generated for any critical findings.
Approvals
Prepared By: ______________________ Date: ____________
Reviewed By: ______________________ Date: ____________
Approved By: ______________________ Date: ____________
Data Integrity Checks
During the PQ process, ensure that:
- All data entries are logged with timestamps.
- Access to the PLC and data logs is restricted to authorized personnel only.
- Regular backups of data are performed and stored securely.