Document Control:
Document ID: DQ-MAG-OSD-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Inline Magnetic Separator
Objective: To establish a comprehensive Design Qualification (DQ) protocol for the Inline Magnetic Separator to ensure it meets the necessary requirements for removing ferrous contamination in Solid Dosage Form production.
Scope: This protocol applies to the Inline Magnetic Separator used in the Production/Material Transfer area for the direct impact on product quality in Solid Dosage Form manufacturing.
Responsibilities:
- Validation Team: Oversee the execution and documentation of the DQ protocol.
- Quality Assurance: Review and approve the DQ documentation.
- Production Team: Provide necessary input regarding equipment operation and maintenance.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Availability of manufacturer’s specifications and installation guidelines.
- Identification of critical parameters and acceptance criteria.
Equipment Description:
The Inline Magnetic Separator is designed to remove ferrous contaminants from the product stream during the production of Solid Dosage Forms. It operates continuously and is integrated into the material transfer system.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001 | Verify magnet strength against manufacturer specifications. | Magnet strength meets or exceeds specified value. | Calibration certificate, manufacturer’s data sheet. |
| DQ-002 | Evaluate capture efficiency using test samples. | Capture efficiency ≥ 99%. | Test results, photographic evidence. |
Detailed Test Cases:
- Test Case ID: DQ-001
- Procedure: Conduct a magnet strength test using a calibrated gauss meter.
- Expected Outcome: Magnet strength is documented and verified.
- Test Case ID: DQ-002
- Procedure: Introduce ferrous particles into the product stream and measure capture efficiency.
- Expected Outcome: Efficiency is recorded and compared against acceptance criteria.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be initiated if acceptance criteria are not met.
Approvals:
Prepared By: ______________________ Date: ___________
Reviewed By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________