Design Qualification Protocol for Peristaltic Pump Used in Controlled Binder Dosing
Document Number: DQ-OSD-PP-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Peristaltic Pump used for controlled binder dosing in the production of solid dosage forms meets the specified requirements and is suitable for its intended use.
Scope
This protocol applies to the validation of the Peristaltic Pump used in the granulation area of the production process for solid dosage forms.
Responsibilities
The validation team is responsible for executing this protocol, ensuring compliance with regulatory requirements, and documenting the results. The Quality Assurance team will review and approve the documentation.
Prerequisites
All personnel involved in the execution of this protocol must be trained in Good Manufacturing Practices (GMP) and have a thorough understanding of the equipment and processes involved.
Equipment Description
The Peristaltic Pump is designed for precise and controlled dosing of binders in the granulation process. It utilizes a flexible tube and rollers to create a vacuum, drawing the binder into the system and delivering it accurately to the mixing vessel.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-1 | Verify flow accuracy and repeatability at designated flow rates. | Flow accuracy within ±5% of target flow rate; repeatability within ±2%. | Calibration records, test data logs. |
Detailed Test Cases
Test Case TP-1
Objective: To assess the flow accuracy and repeatability of the Peristaltic Pump.
Procedure:
- Set the pump to a target flow rate of [Insert Flow Rate].
- Measure the actual flow rate using a calibrated flow meter.
- Record the flow rate and repeat the measurement three times.
Acceptance Criteria: Flow accuracy must be within ±5% of the target flow rate, and repeatability must be within ±2%.
Evidence: Documented flow measurements and calibration certificates.
Deviations
Any deviations from the acceptance criteria or procedures must be documented and assessed for impact on the validation process. A corrective action plan should be developed as necessary.
Approvals
All results and documentation must be reviewed and approved by the Quality Assurance team before the equipment can be considered validated for use in production.