Design Qualification Protocol for Leak Test Machine in Nasal & Otic Products
Document Number: DQ-001
Version: 1.0
Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Design Qualification (DQ) Protocol is to verify that the Leak Test Machine for container closure meets the specified requirements for the production of nasal and otic products.
Scope
This protocol applies to the Leak Test Machine utilized in the Production/QC area for verifying container integrity of nasal and otic products, both sterile and non-sterile.
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 ensuring the equipment is installed and operational prior to DQ execution.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- Operational Qualification (OQ) must be completed and approved.
- Training of personnel on the use of the Leak Test Machine must be completed.
Equipment Description
The Leak Test Machine is an instrument designed to verify the integrity of container closures for nasal and otic products. It employs advanced leak detection technology to ensure compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify leak detection sensitivity | Must detect leaks ≤ 0.5 mL/min | Test report and audit trail |
| DQ-001-02 | Review audit trail functionality | Audit trail must capture all test events | Audit trail log |
Detailed Test Cases
Test Case 1: Leak Detection Sensitivity
Objective: To verify that the machine can detect leaks below the specified threshold.
Procedure: Conduct a series of tests using containers known to have specific leak rates.
Acceptance Criteria: The machine must successfully identify all leaks ≤ 0.5 mL/min.
Evidence: Documented test results and machine readings.
Test Case 2: Audit Trail Review
Objective: To ensure that the audit trail captures all relevant data during operation.
Procedure: Perform a test run and review the audit trail for completeness.
Acceptance Criteria: All events must be logged with appropriate timestamps and user information.
Evidence: Printed audit trail log showing all entries.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A deviation report must be submitted for review and approval.
Approvals
Prepared By: [Insert Name]
Date: [Insert Date]
Approved By: [Insert Name]
Date: [Insert Date]
Data Integrity Checks
Since CSV is required, the following data integrity checks will be implemented:
- Validation of data entry against predefined formats.
- Regular backups of audit trails to prevent data loss.
- Access controls to ensure only authorized personnel can modify data.