Document Control:
Document ID: DQ-OSD-CMD-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Design Qualification Protocol for Capsule Metal Detector
Objective: To establish a Design Qualification (DQ) protocol for the Capsule Metal Detector utilized in the production of solid dosage forms, ensuring it meets specified requirements and standards.
Scope: This protocol applies to the installation and operational qualification of the Capsule Metal Detector in the Production area for solid dosage forms, specifically for detecting metal contaminants in capsules.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Review and approve the DQ protocol and associated documentation.
- Production Personnel: Ensure equipment is operated as per established procedures.
Prerequisites:
- Completion of User Requirements Specification (URS) for the Capsule Metal Detector.
- Installation of the Capsule Metal Detector in the designated production area.
- Training of personnel on equipment operation and safety procedures.
Equipment Description:
The Capsule Metal Detector is designed to detect metal contaminants in capsules during the production process. It operates using advanced sensitivity parameters to ensure that metal particles are identified and rejected effectively, maintaining product quality and safety.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify sensitivity settings against specifications. | Sensitivity settings must meet URS Annex 11 requirements. | Calibration certificate, test results. |
| DQ-002 | Conduct reject verification audit trail. | Audit trail must show all rejected capsules with timestamps. | Audit trail logs. |
Detailed Test Cases:
Test Case 1: Sensitivity Verification
Objective: To ensure the metal detector’s sensitivity is calibrated correctly.
Procedure: Use standard metal pieces to test sensitivity settings.
Expected Result: The detector should identify and reject all test pieces.
Test Case 2: Audit Trail Verification
Objective: To verify that the audit trail accurately reflects the operation of the metal detector.
Procedure: Review the audit trail logs for completeness and accuracy.
Expected Result: The logs should reflect all instances of rejected capsules.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be established to address these deviations.
Approvals:
Prepared by: ______________________ Date: ____________
Reviewed by: ______________________ Date: ____________
Approved by: ______________________ Date: ____________
Data Integrity Checks:
- Ensure all data entries are timestamped.
- Regularly back up audit trail data.
- Implement user access controls to prevent unauthorized changes.