Document Control
Document Number: DQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Barcode Scanner in Solid Dosage Form Production
Objective: To establish a Design Qualification (DQ) protocol for the Barcode Scanner to ensure its compliance with GMP standards for identity verification and traceability in the production and dispensing of solid dosage forms.
Scope: This protocol applies to the Barcode Scanner used in the Production/Dispensing area for identity verification and traceability of solid dosage forms. It covers the validation processes and acceptance criteria as per URS Annex 11 and 21 CFR 11.
Responsibilities:
- Validation Team: Responsible for the execution and documentation of the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- IT Department: Responsible for ensuring the CSV requirements are met and data integrity checks are implemented.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation and operational qualification of the Barcode Scanner.
- Training of personnel on the use of the Barcode Scanner.
Equipment Description:
The Barcode Scanner is a GMP-compliant instrument used for identity verification and traceability in the production and dispensing of solid dosage forms. It captures scan accuracy data and maintains an audit trail to ensure compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify installation of the Barcode Scanner. | Installation meets manufacturer specifications. | Installation report. |
| DQ-02 | Test scan accuracy. | Accuracy of 99% or greater. | Scan accuracy report. |
| DQ-03 | Audit trail functionality check. | Audit trail captures all scans with timestamps. | Audit trail log. |
Detailed Test Cases:
Test Case DQ-01: Verify installation of the Barcode Scanner.
- Procedure: Inspect the physical installation against the manufacturer’s specifications.
- Acceptance Criteria: Installation meets manufacturer specifications.
- Evidence: Documented installation report signed by the validation team.
Test Case DQ-02: Test scan accuracy.
- Procedure: Conduct multiple scans on known barcodes and record accuracy.
- Acceptance Criteria: Accuracy of 99% or greater.
- Evidence: Scan accuracy report detailing results.
Test Case DQ-03: Audit trail functionality check.
- Procedure: Perform a series of scans and review the audit trail for completeness.
- Acceptance Criteria: Audit trail captures all scans with timestamps.
- Evidence: Audit trail log demonstrating functionality.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A corrective action plan should be developed and approved by Quality Assurance.
Approvals:
Prepared By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________