Design Qualification Protocol for Patch Inspection Machine in Transdermal Patches Validation
Document Number: DQ-TP-001
Version: 1.0
Effective Date: 2023-10-01
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Objective
The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Patch Inspection Machine operates in accordance with the User Requirements Specification (URS) and is suitable for its intended use in the inspection of transdermal patches.
Scope
This protocol applies to the Patch Inspection Machine (Vision System) used in the production area for inspecting patch dimensions and defects, impacting product quality directly.
Responsibilities
The Validation Team is responsible for the execution of this DQ protocol, including the documentation and approval of all test results. Quality Assurance will oversee compliance with validation requirements.
Prerequisites
- Completion of Equipment Installation Qualification (IQ)
- Availability of User Requirements Specification (URS) and Acceptance Criteria
- Training of personnel on the operation of the Patch Inspection Machine
Equipment Description
The Patch Inspection Machine (Vision System) is designed to inspect the dimensions and defects of transdermal patches with critical parameters including detection accuracy, reject logic, and audit trail capabilities.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify detection accuracy using standard test patches. | Detection accuracy must be ≥ 98%. | Test results report. |
| T2 | Test reject logic with known defective patches. | Reject logic must function correctly for ≥ 95% of defects. | Reject logic test report. |
| T3 | Audit trail verification through system logs. | Audit trail must log all relevant actions. | Audit trail report. |
Detailed Test Cases
Test Case T1: Detection Accuracy
Procedure: Use standard test patches with known dimensions. Run the inspection cycle and record results.
Expected Outcome: Detection accuracy must be ≥ 98%.
Test Case T2: Reject Logic
Procedure: Introduce known defective patches and observe the machine’s rejection performance.
Expected Outcome: Reject logic must function correctly for ≥ 95% of defects.
Test Case T3: Audit Trail
Procedure: Review system logs for completeness and accuracy of audit trail.
Expected Outcome: Audit trail must log all relevant actions.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Validation Team and Quality Assurance for further action.
Approvals
This protocol must be approved by the Validation Manager and Quality Assurance prior to execution.