Document Number: PQ-001
Version: 1.0
Date: 2023-10-01
Prepared by: Validation Team
Approved by: Quality Assurance
Performance Qualification Protocol for Sterile Powder Compounding Vessel
Objective: To validate the Sterile Powder Compounding Vessel to ensure it meets the required performance criteria for preparing sterile bulk solutions prior to lyophilization.
Scope: This protocol applies to the Sterile Powder Compounding Vessel (Jacketed SS) used in the Production area for the preparation of sterile bulk solutions impacting product quality directly.
Responsibilities:
- Validation Team: Prepare and execute the PQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Operate the equipment as per the validated procedures.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- All personnel trained on equipment operation and safety procedures.
- Availability of necessary materials and equipment for testing.
Equipment Description:
The Sterile Powder Compounding Vessel (Jacketed SS) is designed for the preparation of sterile bulk solutions. It features controlled agitation, temperature regulation, and a PLC audit trail for data integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-01 | Verify agitation speed settings | Agitation speed within specified range | Calibration certificate and log |
| PQ-001-02 | Check temperature control | Temperature held within specified limits | Temperature log |
| PQ-001-03 | Validate hold time | Hold time meets specification | Batch record |
| PQ-001-04 | Review PLC audit trail | Audit trail complete and accurate | PLC report |
Detailed Test Cases:
- Test Case ID: PQ-001-01
- Objective: To ensure the agitation speed is set correctly.
- Procedure: Start the vessel and record the agitation speed.
- Expected Result: Agitation speed should be within the specified range.
- Test Case ID: PQ-001-02
- Objective: To confirm that the temperature control is functioning.
- Procedure: Set the temperature and monitor for stability.
- Expected Result: Temperature should remain within specified limits.
- Test Case ID: PQ-001-03
- Objective: To validate the hold time during the process.
- Procedure: Start the process and record hold time.
- Expected Result: Hold time meets defined specifications.
- Test Case ID: PQ-001-04
- Objective: To ensure the PLC audit trail is complete.
- Procedure: Review the PLC audit trail for accuracy.
- Expected Result: Audit trail should be complete and accurate.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed as per the deviation management procedure.
Approvals:
- Validation Team Lead: _______________________ Date: ___________
- Quality Assurance Manager: _______________________ Date: ___________