Document Control Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Liquid Manufacturing Vessel
Objective: To validate the performance of the Liquid Manufacturing Vessel used for compounding non-sterile liquids, ensuring it meets all critical parameters and acceptance criteria.
Scope: This protocol applies to the Liquid Manufacturing Vessel (SS Jacketed Tank) utilized in the production of oral liquids, syrups, and suspensions within the manufacturing area.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the completed protocol.
- Production Team: Provide necessary support and access to the equipment.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel on the use of the Liquid Manufacturing Vessel.
Equipment Description: The Liquid Manufacturing Vessel is a stainless steel jacketed tank designed for the compounding of non-sterile liquids. It features a PLC for monitoring and control, and is equipped with agitation capabilities to ensure uniform mixing of ingredients.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001-A | Verify agitation speed at specified RPM. | Agitation speed within +/- 5% of set point. | PLC logs, calibration certificates. |
| PQ-001-B | Measure temperature during hold time. | Temperature maintained within specified range. | Temperature logs, calibration certificates. |
| PQ-001-C | Document hold time for compounding. | Hold time meets defined criteria. | Batch records, PLC logs. |
Detailed Test Cases:
- Test Case ID: PQ-001-A
- Procedure: Set the agitation speed to the specified RPM and record the actual speed using the PLC.
- Expected Result: The recorded speed must be within +/- 5% of the set point.
- Test Case ID: PQ-001-B
- Procedure: Initiate the hold time and monitor the temperature using PLC logs.
- Expected Result: The temperature must remain within the specified range throughout the hold time.
- Test Case ID: PQ-001-C
- Procedure: Document the hold time from start to finish during the compounding process.
- Expected Result: The documented hold time must meet the defined criteria.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals:
- Validation Team: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________
Data Integrity Checks:
- Regular audits of PLC logs to ensure data accuracy.
- Backups of critical data to prevent loss.
- Access controls to limit data manipulation.