Document Control:
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for the Dose Metering Test System
Objective: The objective of this Design Qualification (DQ) protocol is to verify that the Dose Metering Test System meets the specified requirements for validating nasal and otic products, ensuring compliance with regulatory standards.
Scope: This protocol applies to the validation of the Dose Metering Test System used in the QC/Production area for 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.
- Equipment Owner: Responsible for ensuring equipment availability and maintenance.
Prerequisites:
- Completion of User Requirement Specification (URS) for the Dose Metering Test System.
- Installation and operational qualification of the equipment.
- Availability of relevant standard operating procedures (SOPs).
Equipment Description:
The Dose Metering Test System is an instrument designed to measure the dose uniformity and spray characteristics of nasal and otic products. It provides data on spray geometry and shot weight, ensuring that the delivered dose meets product specifications.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify dose uniformity | Uniformity within ±10% of target dose | Test results report |
| DQ-001-02 | Assess spray geometry | Spray pattern conforms to specifications | Photographic evidence |
| DQ-001-03 | Audit trail verification | Complete and accurate audit trail | Audit trail log |
Detailed Test Cases:
- Test Case 1: Conduct dose uniformity test using specified methodology. Document results and compare against acceptance criteria.
- Test Case 2: Perform spray geometry assessment. Capture images and compare against established specifications.
- Test Case 3: Review audit trail functionality. Ensure all actions are logged and retrievable.
Deviations: Any deviations from the established protocol must be documented and justified. A plan for resolution must be outlined.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: _______________ Date: ___________
Data Integrity Checks:
- Ensure data input is validated against predefined formats.
- Implement access controls to restrict unauthorized changes.
- Regularly back up data to prevent loss.