Document Control:
Document ID: OQ-SS-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Solvent Storage Tank in API Manufacturing
Objective: To establish the operational qualification (OQ) of the Solvent Storage Tank to ensure it meets the required specifications and performance criteria for storing solvents in the production area.
Scope: This protocol applies to the Solvent Storage Tank used for solvent storage in API manufacturing processes, focusing on the verification of critical parameters.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for providing access and support during testing.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All necessary documentation and equipment must be available and functioning.
Equipment Description:
The Solvent Storage Tank (SS / GL) is designed to store solvents used in the chemical synthesis and purification processes within the production area. The tank is equipped with level, temperature, and pressure sensors, and is controlled via a PLC with an audit trail log feature.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify level sensor calibration | Calibration within specified limits | Calibration certificate |
| OQ-02 | Verify temperature sensor accuracy | Temperature within specified limits | Temperature log |
| OQ-03 | Verify pressure sensor functionality | Pressure readings within specified limits | Pressure log |
| OQ-04 | Check PLC audit trail logs | Complete and accurate logs maintained | Audit trail report |
Detailed Test Cases:
- Test Case OQ-01: Verify the calibration of the level sensor. Document the calibration procedure and results.
- Test Case OQ-02: Measure the temperature using a calibrated thermometer and compare it with the temperature sensor reading.
- Test Case OQ-03: Apply known pressure to the tank and verify the pressure sensor readings against the applied pressure.
- Test Case OQ-04: Review the PLC audit trail logs for completeness and accuracy over a defined period.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.
Approvals:
All results must be reviewed and approved by the Quality Assurance department before final acceptance of the OQ protocol.