Operational Qualification Protocol for Peristaltic Pump in Solid Dosage Form
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Peristaltic Pump used for controlled binder dosing in Solid Dosage Form (OSD) production operates within specified limits and meets the requirements outlined in the User Requirement Specification (URS).
Scope
This protocol applies to the Peristaltic Pump utilized in the Production/Granulation area for the direct dosing of binder in the OSD process. It covers the qualification of the equipment’s performance concerning flow accuracy repeatability.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Team: Responsible for providing necessary access to the equipment and supporting the validation process.
Prerequisites
- Completion of Installation Qualification (IQ) for the Peristaltic Pump.
- Availability of the User Requirement Specification (URS) document.
- Training of personnel on the operation of the Peristaltic Pump.
Equipment Description
The Peristaltic Pump is designed for controlled binder dosing in the production of solid dosage forms. It utilizes a series of rollers to compress a flexible tube, creating a vacuum that draws the binder into the pump and delivers it at a specified flow rate.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Measure flow rate at specified settings. | Flow rate within ±5% of target. | Flow rate measurement log. |
| OQ-02 | Perform repeatability test over 10 cycles. | Standard deviation of flow rate < 2% of mean. | Statistical analysis report. |
Detailed Test Cases
Test Case OQ-01
Objective: To verify the flow rate accuracy of the Peristaltic Pump.
Procedure: Set the pump to the target flow rate, measure the output over a specified time period.
Acceptance Criteria: Flow rate must be within ±5% of the target.
Evidence: Document flow rate measurements in the log.
Test Case OQ-02
Objective: To assess the repeatability of the flow rate.
Procedure: Run the pump at the target flow rate for 10 cycles, recording the flow rate for each cycle.
Acceptance Criteria: Standard deviation must be less than 2% of the mean flow rate.
Evidence: Provide statistical analysis report demonstrating results.
Deviations
Any deviations from the acceptance criteria will be documented and assessed for impact on product quality. A root cause analysis will be performed, and corrective actions will be implemented as necessary.
Approvals
The undersigned approve this Operational Qualification Protocol and confirm that it meets the requirements set forth in the User Requirement Specification (URS).
Validation Team Lead: ______________________ Date: ____________
Quality Assurance: ______________________ Date: ____________
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