Design Qualification Protocol for Vent Filter Assembly in Nasal & Otic Products
Document Control:
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Vent Filter Assembly used in the production of nasal and otic products maintains the sterility of the holding vessel, thereby ensuring product integrity and compliance with regulatory requirements.
Scope
This protocol applies to the Design Qualification of the Vent Filter Assembly utilized in the production area for both sterile and non-sterile nasal and otic products.
Responsibilities
The following personnel are responsible for the execution and approval of this DQ protocol:
- Validation Team: Execute the DQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Ensure proper operation of the Vent Filter Assembly during production.
Prerequisites
Prior to executing this DQ protocol, the following must be completed:
- Installation Qualification (IQ) of the Vent Filter Assembly.
- Training of personnel on the operation of the Vent Filter Assembly.
Equipment Description
The Vent Filter Assembly is a critical component used to maintain sterility in the holding vessel during the production of nasal and otic products. It is designed to allow gas exchange while preventing contamination from airborne particles.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001 | Perform integrity pressure hold test | Pass if integrity is maintained for specified duration | Test report and logs |
Detailed Test Cases
Test Case 1: Integrity Pressure Hold Test
Objective: To verify that the Vent Filter Assembly maintains integrity under pressure.
Procedure:
1. Connect the Vent Filter Assembly to the pressure testing apparatus.
2. Apply the specified pressure as per URS Annex1.
3. Monitor for leaks or pressure drop for the defined duration.
Acceptance Criteria: No pressure drop should occur during the test duration.
Evidence: Documented test results and pressure logs.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and approved by the Quality Assurance team prior to proceeding with production.
Approvals
This protocol must be reviewed and approved by the following personnel:
- Validation Manager: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________
- Production Manager: ______________________ Date: __________