Document ID: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Performance Qualification Protocol for Solution Preparation Tank
Objective: To validate the performance of the Solution Preparation Tank used in the production of Nasal and Otic Products, ensuring it meets the specified requirements for quality and safety.
Scope: This protocol applies to the Solution Preparation Tank used in the production area for the preparation of sterile and non-sterile formulations impacting product quality directly.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ documentation.
- Production Team: Ensure equipment is operated according to SOPs during testing.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment for testing.
- Staff trained on equipment operation and safety procedures.
Equipment Description:
The Solution Preparation Tank is designed for dissolving ingredients and preparing formulations for nasal and otic products. It features controlled temperature, mixing speed, and conductivity monitoring, with PLC logs for data integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-T1 | Verify temperature control within specified range. | Temperature maintained within ±2°C of setpoint. | Temperature logs from PLC. |
| PQ-001-T2 | Measure mixing speed during operation. | Mixing speed within ±10% of target. | Mixing speed logs from PLC. |
| PQ-001-T3 | Check conductivity of solution. | Conductivity within specified limits. | Conductivity measurements recorded. |
Detailed Test Cases:
- Test Case 1: Set the temperature to the desired setpoint and monitor for stability over a 30-minute period. Document any deviations.
- Test Case 2: Initiate mixing and measure the speed at intervals of 5 minutes for 30 minutes. Ensure readings align with acceptance criteria.
- Test Case 3: Prepare a standard solution and measure its conductivity. Compare with acceptance criteria and document results.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Root cause analysis should be performed to determine the impact on product quality.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Quality Assurance)
- ____________________ (Production Manager)
Data Integrity Checks: Ensure all PLC logs are backed up and securely stored. Conduct regular audits of data entries and logs to confirm accuracy and completeness.