Document Control Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Operational Qualification Protocol for Liquid Manufacturing Vessel
Objective: To ensure that the Liquid Manufacturing Vessel operates within specified parameters and meets the requirements set forth in the User Requirements Specification (URS) Annex 11.
Scope: This protocol applies to the Operational Qualification (OQ) of the Liquid Manufacturing Vessel used for compounding non-sterile liquids in the Production/Manufacturing area.
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ protocol and results.
- Production: Ensure the equipment is prepared and maintained for testing.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All necessary materials and resources must be available.
Equipment Description:
The Liquid Manufacturing Vessel is a stainless steel jacketed tank designed for the compounding of syrups and suspensions. It features precise control of agitation speed, temperature, and hold time, with data logging capabilities via PLC.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify agitation speed at specified RPM. | Agitation speed within ±10% of set point. | PLC logs, calibration records. |
| OQ-002 | Measure temperature during operation. | Temperature maintained within ±2°C of set point. | Temperature logs, PLC logs. |
| OQ-003 | Confirm hold time during processing. | Hold time within ±5% of specified duration. | Time logs, PLC logs. |
Detailed Test Cases:
- Test Case OQ-001: Set agitation speed to 100 RPM. Monitor and record speed for 10 minutes. Check PLC logs for consistency.
- Test Case OQ-002: Set temperature to 60°C. Monitor for 30 minutes. Record temperature at 5-minute intervals. Review logs for deviations.
- Test Case OQ-003: Start the process and record start time. Ensure hold time of 15 minutes is maintained. Document end time and calculate duration.
Deviations: Any deviations from acceptance criteria must be documented and investigated. Root cause analysis should be performed, and corrective actions implemented as necessary.
Approvals:
____________________
Validation Team Lead
____________________
Quality Assurance Manager
Data Integrity Checks:
- Regular audits of PLC logs to ensure data accuracy.
- Backup of data logs to secure storage after each batch.
- Cross-verification of manual logs against PLC data.