Document Control:
- Document ID: PQ-SKID-001
- Version: 1.0
- Effective Date: YYYY-MM-DD
- Reviewed By: [Name]
- Approved By: [Name]
Performance Qualification Protocol for Sterile Filtration Skid
Objective: To validate the performance of the Sterile Filtration Skid used for filtering sterile bulk solutions in the production of prefilled syringes and cartridges.
Scope: This protocol applies to the Sterile Filtration Skid located in the Production area and is intended for use in the filtration of sterile bulk solutions that directly impact product quality.
Responsibilities:
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the equipment as per the validated procedures.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Completion of Operational Qualification (OQ).
- Training of personnel on equipment operation and validation procedures.
Equipment Description:
The Sterile Filtration Skid is designed for the filtration of sterile bulk solutions, ensuring the removal of particulates and microorganisms. The system operates under controlled conditions to maintain sterility and integrity of the product.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Flow DP integrity audit trail logs review | All logs must be complete and within specified parameters as per URS Annex1 Annex11. | Audit trail logs documentation |
Detailed Test Cases:
- Test Case ID: PQ-001
- Objective: Verify the integrity of flow DP through the Sterile Filtration Skid.
- Procedure: Review the audit trail logs for the flow DP parameters during operation.
- Expected Outcome: All parameters should be logged accurately and within the acceptance criteria.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed for any critical deviations.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance Manager: ____________________ Date: ___________