Performance Qualification Protocol for Solvent Storage Tank in API Manufacturing
Document ID: PQ-SS-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed by: [Name]
Approved by: [Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Solvent Storage Tank operates within specified limits and meets the requirements outlined in the User Requirement Specification (URS), Annex 11, and Annex 15.
Scope
This protocol applies to the Solvent Storage Tank (SS / GL) used in the production area for the storage of solvents in API manufacturing. The PQ will cover critical parameters related to the equipment’s operation.
Responsibilities
The Validation Team is responsible for the execution of this PQ protocol, ensuring compliance with regulatory requirements and internal standards.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel involved in the PQ activities.
Equipment Description
The Solvent Storage Tank is designed to store solvents used in chemical synthesis and purification processes. It features a PLC-controlled system for monitoring and controlling critical parameters including level, temperature, and pressure.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify level measurement accuracy | Level readings within ±5% of the actual level | Calibration certificate, logbook entries |
| PQ-02 | Verify temperature control | Temperature maintained within specified range | Temperature logs, PLC audit trail |
| PQ-03 | Verify pressure control | Pressure maintained within specified range | Pressure logs, PLC audit trail |
Detailed Test Cases
Test Case PQ-01: Verify Level Measurement Accuracy
Procedure: Measure the solvent level using the tank’s level indicator and compare it with a calibrated measuring device.
Acceptance Criteria: Level readings must be within ±5% of the actual level.
Evidence: Documented results, calibration certificate.
Test Case PQ-02: Verify Temperature Control
Procedure: Monitor the temperature of the solvent in the tank over a defined period.
Acceptance Criteria: Temperature must be maintained within the specified range.
Evidence: Temperature logs, PLC audit trail logs.
Test Case PQ-03: Verify Pressure Control
Procedure: Monitor the pressure within the tank during operation.
Acceptance Criteria: Pressure must be maintained within the specified range.
Evidence: Pressure logs, PLC audit trail logs.
Deviations
Any deviations from the acceptance criteria must be documented, including the reason for the deviation and the corrective actions taken.
Approvals
Prepared by: [Name] – [Date]
Reviewed by: [Name] – [Date]
Approved by: [Name] – [Date]
Data Integrity Checks
- Ensure that all PLC audit trails are enabled and functioning correctly.
- Verify that all data logs are time-stamped and securely stored.
- Conduct periodic reviews of log integrity and access controls.