Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for the Centrifugal Sifter
Objective: To validate the operational performance of the Centrifugal Sifter used in the production of Solid Dosage Forms, ensuring compliance with defined acceptance criteria and operational requirements.
Scope: This protocol applies to the operational qualification of the Centrifugal Sifter located in the Production/Sieving area, focusing on high-throughput sifting processes that directly impact product quality.
Responsibilities:
- Validation Team: Prepare, execute, and document the OQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide support during testing and ensure equipment is available.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved must be trained on the equipment and procedures.
Equipment Description:
The Centrifugal Sifter is designed for high-throughput sifting of solid dosage forms, ensuring the integrity of the product by removing oversized particles and contaminants. Key critical parameters include rotor speed and screen integrity, which are essential for maintaining product quality.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify rotor speed at specified settings. | Rotor speed within ±10% of specified range. | Calibration logs and speed measurement data. |
| OQ-02 | Inspect screen integrity for wear and tear. | No visible damage or excessive wear. | Inspection report and photographic evidence. |
Detailed Test Cases:
- Test Case OQ-01: Measure the rotor speed using a calibrated tachometer at the operational settings of the sifter. Record the speeds and compare against the acceptance criteria.
- Test Case OQ-02: Conduct a visual inspection of the sifter screen before and after operation. Document any findings related to wear or damage.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Root cause analysis should be performed, and corrective actions must be implemented as necessary.
Approvals:
- Prepared by: ______________________
- Reviewed by: ______________________
- Approved by: ______________________