Installation Qualification Protocol for Sterile Filtration Skid
Document Control Number: IQ-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Sterile Filtration Skid is installed correctly and operates according to the specified requirements to ensure compliance with regulatory standards.
Scope
This protocol applies to the Installation Qualification of the Sterile Filtration Skid used in the production area for filtering sterile bulk solutions for prefilled syringes and cartridges.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol.
- Engineering: Responsible for ensuring equipment is installed per specifications.
Prerequisites
- Completion of Equipment Installation.
- Availability of necessary documentation (URS, specifications, etc.).
- Training of personnel on equipment operation and validation procedures.
Equipment Description
The Sterile Filtration Skid is a system designed for the filtration of sterile bulk solutions. It operates under controlled conditions to ensure the sterility and integrity of the product. Key features include:
- Flow DP integrity audit trail logs
- Automated controls for process monitoring
- Compliance with URS Annex 1 and Annex 11
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-001 | Verify installation per engineering specifications | All components installed as per specifications | Installation checklist |
| IQ-002 | Check functionality of flow DP integrity audit trail logs | Logs show accurate data and no discrepancies | Audit trail report |
Detailed Test Cases
Test Case 1: Installation Verification
Objective: Confirm that all equipment components are installed according to specifications.
Procedure: Review the installation checklist and compare with the actual installation.
Acceptance Criteria: All components must match the specifications outlined in the engineering documents.
Evidence: Completed installation checklist with signatures.
Test Case 2: Flow DP Integrity Audit Trail Verification
Objective: Ensure the flow DP integrity audit trail logs are functioning properly.
Procedure: Simulate operation and check the audit trail logs for accuracy and completeness.
Acceptance Criteria: Audit trail logs must indicate no discrepancies and must be complete.
Evidence: Extracted audit trail logs for review.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report should be generated for any non-conformance.
Approvals
This protocol must be approved by the following personnel:
- Validation Manager: ___________________ Date: ___________
- Quality Assurance Manager: ____________ Date: ___________
- Engineering Manager: ________________ Date: ___________