Document Control Number: DQ-OSD-001
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for Screw Capper in Solid Dosage Form
Objective: To outline the design qualification protocol for the Screw Capper used in the packaging of solid dosage forms, ensuring compliance with regulatory standards and product quality.
Scope: This document applies to the design qualification of the Screw Capper located in the Packaging/Primary area, impacting the direct quality of the product.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical support and ensuring equipment functionality.
Prerequisites:
- Completion of User Requirement Specification (URS) as per Annex 11.
- Installation Qualification (IQ) must be completed prior to DQ execution.
- All personnel involved must be trained on the equipment and procedures.
Equipment Description:
The Screw Capper is designed for capping bottles with a torque range adjustable to meet product specifications. The equipment includes speed control, reject sensors, and an audit trail feature to ensure compliance and traceability.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify torque range settings | Torque settings must be within specified range as per URS. | Calibration records, test results. |
| DQ-002 | Check speed control functionality | Speed must be adjustable and meet operational requirements. | Operational logs, test results. |
| DQ-003 | Test reject sensor functionality | Reject sensors must accurately identify and reject defective caps. | Test results, sensor calibration records. |
| DQ-004 | Verify audit trail capability | Audit trail must capture all relevant events and be retrievable. | Audit trail logs, test results. |
Detailed Test Cases:
- Test Case 1: Verify that the torque range is set correctly and is adjustable as per the specifications defined in the URS. Record the torque values before and after adjustment.
- Test Case 2: Perform a speed test to ensure that the equipment operates at the required speeds. Document any deviations from the expected speeds.
- Test Case 3: Conduct a functional test of the reject sensors by introducing defective caps. Ensure that all defective caps are rejected as per the specifications.
- Test Case 4: Access the audit trail and verify that all operations are logged correctly, including timestamps and operator IDs.
Deviations: Any deviations from the acceptance criteria must be documented and addressed in a deviation report. Root cause analysis may be required for critical deviations.
Approvals:
- Prepared by: ______________________ Date: ___________
- Reviewed by: ______________________ Date: ___________
- Approved by: ______________________ Date: ___________
Data Integrity Checks:
- Ensure that all data entered into the system is verified through dual control.
- Regular backups of audit trail data must be performed to prevent data loss.
- Access controls must be implemented to restrict unauthorized access to critical data.