Document Control:
Document Number: DQ-AVI-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Automated Visual Inspection System
Objective: To establish a Design Qualification (DQ) protocol for the Automated Visual Inspection (AVI) System used in NDDS packaging and integrity, ensuring compliance with regulatory requirements and operational specifications.
Scope: This protocol applies to the Automated Visual Inspection System utilized in the production area for the direct inspection of particulate and cosmetic defects in products.
Responsibilities:
- Validation Team: Develop, execute, and document the DQ protocol.
- Quality Assurance: Review and approve the DQ documentation.
- Production Team: Ensure the system is operated according to the validated procedures.
Prerequisites:
- Completion of User Requirement Specification (URS) as per Annex 11.
- Installation Qualification (IQ) documentation completed.
- Operational Qualification (OQ) protocol developed.
Equipment Description: The Automated Visual Inspection (AVI) System is designed to perform particulate and cosmetic inspections of pharmaceutical products. It employs advanced imaging technology to detect defects, ensuring product integrity before packaging.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-AVI-001 | Verify detection sensitivity | Must detect ≥ 99% of defects | Test results report |
| DQ-AVI-002 | Validate reject logic | Reject ≥ 95% of defective products | Audit trail log |
| DQ-AVI-003 | Audit trail verification | Audit trail must be complete and accurate | Audit trail review document |
Detailed Test Cases:
- Test Case 1: Execute detection sensitivity test using known defect samples. Document results and compare with acceptance criteria.
- Test Case 2: Simulate product flow and record the system’s reject logic. Validate against expected outcomes.
- Test Case 3: Review the audit trail for completeness. Ensure all actions are logged and retrievable.
Deviations: Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the DQ protocol.
Approvals:
- ______________________ (Validation Team Lead)
- ______________________ (Quality Assurance)
- ______________________ (Production Manager)
Data Integrity Checks:
- Ensure data entered into the system is validated against predefined criteria.
- Regularly review audit trails to confirm no unauthorized changes have been made.
- Implement routine backups of inspection data to prevent loss.