Document Control:
Document Number: DQ-NSFM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Nasal Spray Filling Machine
Objective: To establish and document the Design Qualification (DQ) for the Nasal Spray Filling Machine, ensuring it meets the specified requirements for filling nasal spray bottles in a controlled production environment.
Scope: This protocol applies to the Nasal Spray Filling Machine used in the production area for the filling of sterile and non-sterile nasal spray products. It covers the validation of equipment critical to product quality and compliance with applicable regulations.
Responsibilities:
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the DQ protocol and results.
- Production Team: Provide operational input and support during the qualification process.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) and Operational Qualification (OQ) protocols must be planned.
- Availability of necessary documentation and training for personnel.
Equipment Description:
The Nasal Spray Filling Machine is designed for filling nasal spray bottles with precise accuracy. It operates in a controlled environment to ensure product sterility and compliance with regulatory requirements. Key features include:
- Fill accuracy reject logic
- Audit trail for process monitoring
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify fill accuracy of the machine. | Fill accuracy within +/- 5% of target volume. | Calibration report and test results. |
| DQ-02 | Check reject logic functionality. | Machine must reject out-of-spec fills. | Test results and machine log. |
| DQ-03 | Review audit trail for compliance. | Audit trail must show all operations and events. | Audit trail report. |
Detailed Test Cases:
- Test Case ID: DQ-01-01
- Objective: To verify the fill accuracy.
- Procedure: Conduct fill tests using calibrated measuring devices.
- Expected Result: All fills within specified accuracy limits.
- Test Case ID: DQ-02-01
- Objective: To ensure reject logic functions correctly.
- Procedure: Simulate out-of-spec fills and observe machine behavior.
- Expected Result: Machine rejects out-of-spec fills as intended.
- Test Case ID: DQ-03-01
- Objective: To confirm the audit trail captures all relevant data.
- Procedure: Review the audit trail for completeness post-testing.
- Expected Result: Audit trail reflects all operations and events accurately.
Deviations: Any deviations from the acceptance criteria or procedures must be documented and assessed for impact on product quality and compliance. A deviation report must be submitted for review and approval.
Approvals:
- Prepared by: [Name, Title]
- Reviewed by: [Name, Title]
- Approved by: [Name, Title]