Document Control
Document Title: Operational Qualification Protocol for Dose Metering Test System
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Dose Metering Test System
Objective
The objective of this Operational Qualification (OQ) protocol is to verify the Dose Metering Test System’s ability to deliver the specified dose and maintain spray characteristics as per the defined acceptance criteria.
Scope
This protocol applies to the Dose Metering Test System utilized in the Quality Control and Production areas for nasal and otic products, both sterile and non-sterile.
Responsibilities
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ protocol and results.
- Production Personnel: Ensure the equipment is maintained and calibrated.
Prerequisites
- Equipment must be installed and calibrated as per manufacturer’s specifications.
- All operators must be trained on equipment usage and safety procedures.
- Relevant SOPs must be reviewed and understood.
Equipment Description
The Dose Metering Test System is an instrument designed to measure the delivered dose and evaluate the spray characteristics of nasal and otic products. It provides critical data for ensuring product quality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify dose uniformity by conducting multiple dose measurements. | All measurements must fall within ±10% of the target dose. | Recorded dose measurements log. |
| OQ-001-02 | Evaluate spray geometry using calibrated imaging. | Spray pattern must conform to specifications outlined in the URS Annex11. | Spray pattern images and analysis report. |
| OQ-001-03 | Audit trail verification for data integrity. | All data must be logged with timestamps and user identification. | Audit trail report. |
Detailed Test Cases
Test Case OQ-001-01: Dose Uniformity
Measure the delivered dose from the system at least 10 times. Document each measurement and calculate the mean and standard deviation. Ensure all results meet the acceptance criteria.
Test Case OQ-001-02: Spray Geometry
Use a calibrated imaging system to capture the spray pattern. Compare the captured images against the specifications in the URS Annex11. Document any deviations.
Test Case OQ-001-03: Audit Trail Verification
Access the system’s audit trail and verify that all data entries are complete with timestamps and user IDs. Document any discrepancies found during the audit.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report must be submitted for review and approval.
Approvals
This document requires approval from the Validation Team and Quality Assurance before implementation.