Document ID: PQ-OSD-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Performance Qualification Protocol for Peristaltic Pump in Binder Addition
This document outlines the Performance Qualification (PQ) protocol for the Peristaltic Pump used in the controlled dosing of binder during the solid dosage form production process.
Objective: To validate the performance of the Peristaltic Pump in ensuring accurate and repeatable flow rates for binder addition during granulation.
Scope: This protocol applies to the Peristaltic Pump utilized in the production area for the controlled dosing of binder in the granulation process of solid dosage forms.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ protocol and results.
- Production Team: Ensure equipment is set up and maintained as per protocol requirements.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ) for the Peristaltic Pump.
- Training of personnel on the use of the Peristaltic Pump.
Equipment Description:
The Peristaltic Pump is designed for the precise and controlled dosing of binder in the granulation process. It utilizes flexible tubing to transport fluids and is capable of delivering consistent flow rates.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure flow rate at specified settings. | Flow accuracy within ±5% of target rate. | Flow rate measurements and calibration records. |
| PQ-02 | Conduct repeatability tests over multiple runs. | Standard deviation of flow rate ≤ 2%. | Statistical analysis of flow rate data. |
Detailed Test Cases:
- Test Case PQ-01: Set the pump to a target flow rate of X mL/min, measure the actual flow rate using calibrated equipment, and compare against the acceptance criteria.
- Test Case PQ-02: Run the pump for 10 cycles at the same flow rate setting, record flow rates, and calculate the standard deviation to assess repeatability.
Deviations:
Any deviations from the acceptance criteria must be documented, and a root cause analysis should be conducted to determine corrective actions.
Approvals:
All results must be reviewed and approved by the Quality Assurance department prior to final validation.