Document Control:
Document ID: OQ-DIST-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval: [Insert Name]
Operational Qualification Protocol for Distillation Unit in API Manufacturing
Objective: To establish the operational qualification (OQ) of the Distillation Unit used for solvent purification or recovery in API manufacturing, ensuring it meets all critical parameters and acceptance criteria.
Scope: This protocol applies to the operational qualification of the Distillation Unit within the Production area, specifically for solvent purification or recovery processes impacting the product directly.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the equipment during testing.
Prerequisites:
- Completion of Installation Qualification (IQ) for the Distillation Unit.
- Availability of all necessary documentation including User Requirement Specification (URS) and CSV documentation.
Equipment Description: The Distillation Unit is a critical piece of equipment utilized for solvent purification and recovery in the API manufacturing process. It operates under controlled temperature and pressure conditions with a defined reflux ratio, monitored by a PLC with audit trail logs.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-DIST-001-01 | Verify temperature control during operation. | Temperature remains within specified limits. | Temperature logs from PLC. |
| OQ-DIST-001-02 | Verify pressure control during operation. | Pressure remains within specified limits. | Pressure logs from PLC. |
| OQ-DIST-001-03 | Verify reflux ratio during operation. | Reflux ratio meets specified criteria. | Reflux ratio logs from PLC. |
| OQ-DIST-001-04 | Review PLC audit trail logs. | No discrepancies found in logs. | Audit trail report. |
Detailed Test Cases:
1. **Temperature Verification:**
– Start the Distillation Unit and set to operational parameters.
– Record temperature at specified intervals.
– Compare against acceptance criteria.
2. **Pressure Verification:**
– Start the Distillation Unit and set to operational parameters.
– Record pressure at specified intervals.
– Compare against acceptance criteria.
3. **Reflux Ratio Verification:**
– Start the Distillation Unit and set to operational parameters.
– Measure and record reflux ratio.
– Compare against acceptance criteria.
4. **Audit Trail Review:**
– Access PLC audit trail logs.
– Verify no discrepancies or anomalies exist.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be generated and reviewed by the Quality Assurance team.
Approvals:
- Validation Team Lead: ______________________
- Quality Assurance: ______________________
- Production Supervisor: ______________________
Data Integrity Checks: As CSV is required, ensure that all data logged from PLC is backed up and verified for accuracy. Regular audits of data integrity should be conducted to ensure compliance with regulatory standards.