Performance Qualification Protocol for Sterile Grade Filter Housing in Ophthalmics Production
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Sterile Grade Filter Housing operates effectively under specified conditions to ensure the integrity of the sterilizing-grade filter used in the production of ophthalmic products.
Scope
This protocol applies to the Performance Qualification of the Sterile Grade Filter Housing utilized in the production area for ophthalmics, specifically for sterile eye drops and eye ointments.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Personnel: Responsible for ensuring the equipment is operated as per the protocol.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of required documentation, including URS Annex1.
- Training of personnel on the operation of the equipment.
Equipment Description
The Sterile Grade Filter Housing is designed to hold sterilizing-grade filters used in the production of sterile ophthalmic products. It is critical for maintaining the sterility of the product during the filtration process.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Pressure Hold Test | Pressure must hold for 30 minutes without drop. | Pressure log data. |
Detailed Test Cases
Test Case 1: Pressure Hold Test
Objective: To ensure the integrity of the seal under pressure.
Procedure:
1. Connect the filter housing to the pressure monitoring system.
2. Apply the specified pressure as per URS Annex1.
3. Monitor and record the pressure for 30 minutes.
Acceptance Criteria: Pressure must hold steady without any drop for the entire duration.
Evidence: Documented pressure readings from the monitoring system.
Deviations
Any deviations from the established protocol must be documented and justified. If acceptance criteria are not met, a root cause analysis must be performed, and corrective actions must be implemented.
Approvals
Prepared by: [Name, Title, Date]
Reviewed by: [Name, Title, Date]
Approved by: [Name, Title, Date]