Document Control:
Document Number: DQ-OSD-VS-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Design Qualification Protocol for Vision System in Solid Dosage Form Equipment Validation
Meta Description: This document outlines the Design Qualification protocol for the Vision System used in Solid Dosage Form Equipment Validation, ensuring compliance with URS Annex11 standards.
Tags: Equipment Validation, Design Qualification, Vision System, OSD, Packaging, Inspection
Objective
The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Vision System for label and code verification in Solid Dosage Form (OSD) packaging meets the specified requirements for functionality, accuracy, and compliance with regulatory standards.
Scope
This protocol applies to the Vision System utilized in the packaging and inspection area for verifying print and label correctness of solid dosage forms. This includes all relevant testing and documentation to ensure the system’s criticality is addressed.
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: Ensure the Vision System is installed and functioning as intended.
Prerequisites
- Installation Qualification (IQ) must be completed prior to DQ execution.
- All personnel involved must be trained on the Vision System operation and validation processes.
Equipment Description
The Vision System is a critical inspection system designed to verify the correctness of print and labels on solid dosage forms. Key features include detection accuracy, reject logic, and an audit trail for compliance tracking.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify detection accuracy | ≥ 99% accuracy | Test report |
| DQ-002 | Audit trail functionality check | Complete audit trail generated | System logs |
| DQ-003 | Reject logic verification | All incorrect labels rejected | Test report |
Detailed Test Cases
Test Case for Detection Accuracy
Objective: To verify the detection accuracy of the Vision System.
Procedure: Perform a series of tests with known correct and incorrect labels.
Expected Result: The system should correctly identify and reject incorrect labels with ≥ 99% accuracy.
Test Case for Audit Trail Functionality
Objective: To ensure the audit trail feature is functioning correctly.
Procedure: Execute multiple inspections and verify that each action is logged correctly.
Expected Result: A complete audit trail should be generated for all actions taken by the system.
Test Case for Reject Logic
Objective: To confirm the reject logic of the Vision System.
Procedure: Test the system with a set of incorrect labels and observe the reject mechanism.
Expected Result: All incorrect labels should be rejected by the system.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality and compliance. A corrective action plan should be developed as necessary.
Approvals
Prepared by: ______________________ Date: ____________
Reviewed by: ______________________ Date: ____________
Approved by: ______________________ Date: ____________