Document Control
Document Number: PQ-LSS-001
Revision Number: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Lyophilizer Stoppering System
Objective: To validate the performance of the Lyophilizer Stoppering System to ensure it meets the specified requirements for fully inserting stoppers post-lyophilization.
Scope: This protocol applies to the Lyophilizer Stoppering System used in the production area for sterile powders and lyophilized products.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary support and equipment access.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel involved in the validation process.
Equipment Description:
The Lyophilizer Stoppering System is designed to fully insert stoppers post-lyophilization. It is a critical system in the production of sterile powders and lyophilized products, ensuring product integrity and sterility.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-LSS-01 | Verify stopper insertion force using calibrated force gauge. | Stoppering force must align with specifications in URS Annex11. | Force gauge log and alignment audit trail. |
| PQ-LSS-02 | Review audit trail logs for stopper insertion. | All logs must be complete and without discrepancies. | Audit trail report. |
Detailed Test Cases:
- Test Case 1: Measure and document the stopper insertion force. Ensure that the force is within the acceptable range as specified in URS Annex11. Record results in the validation log.
- Test Case 2: Verify that the audit trail logs are generated correctly during the stopper insertion process. Any missing data must be investigated and resolved.
Deviations: Any deviations from the acceptance criteria must be documented and addressed according to the deviation management process.
Approvals:
- Prepared by: [Insert Name]
- Reviewed by: [Insert Name]
- Approved by: [Insert Name]
Data Integrity Checks: Ensure that all data captured during the qualification is stored securely and protected from unauthorized access. Regular audits of the data integrity should be conducted to maintain compliance.