Document Control
Document Title: Performance Qualification Protocol for Distillation Unit
Document Number: PQ-DU-001
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Distillation Unit
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Distillation Unit for solvent purification and recovery in the API manufacturing process to ensure compliance with regulatory requirements and product quality standards.
Scope
This protocol applies to the Distillation Unit used in the production area for the purification and recovery of solvents directly impacting product quality.
Responsibilities
The validation team is responsible for executing this protocol, documenting results, and ensuring compliance with the acceptance criteria. Quality Assurance (QA) will review and approve the final report.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
- Availability of necessary documentation including User Requirement Specification (URS), Annex 11, and Annex 15.
- Training of personnel on the operation of the Distillation Unit.
Equipment Description
The Distillation Unit is designed for solvent purification or recovery through a controlled distillation process. Key features include temperature and pressure control, reflux ratio adjustment, and integration with PLC for data logging.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-01 | Verify temperature control functionality. | Temperature remains within ±2°C of setpoint. | Temperature logs. |
| TP-02 | Verify pressure control functionality. | Pressure remains within ±5% of setpoint. | Pressure logs. |
| TP-03 | Check reflux ratio settings. | Reflux ratio matches specified settings. | PLC audit trail logs. |
Detailed Test Cases
Test Case: TP-01
Objective: To ensure the temperature control system of the Distillation Unit operates within specified limits.
Method: Set the temperature to the desired setpoint and monitor for stability over 30 minutes.
Expected Result: Temperature remains within ±2°C of the setpoint.
Test Case: TP-02
Objective: To validate the pressure control system of the Distillation Unit.
Method: Set the pressure to the desired setpoint and monitor for stability over 30 minutes.
Expected Result: Pressure remains within ±5% of the setpoint.
Test Case: TP-03
Objective: To verify the reflux ratio settings.
Method: Adjust the reflux ratio and validate against the specified settings using PLC logs.
Expected Result: Reflux ratio matches specified settings.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis will be performed for any critical deviations.
Approvals
This protocol requires approval from the Quality Assurance department prior to execution. Signatures from the validation team and QA are required at the conclusion of the testing.
Data Integrity Checks
- Ensure all temperature and pressure logs are timestamped and stored securely.
- Validate that PLC audit trail logs are complete and unaltered.
- Cross-check recorded parameters against manual readings at regular intervals.