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Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Stoppering Machine in IV Infusions
Meta Description: This document outlines the Performance Qualification protocol for the Stoppering Machine used in the production of IV Infusions (LVP/SVP – Bags/Bottles), ensuring compliance with URS Annex11.
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Stoppering Machine functions as intended, ensuring proper placement of stoppers in IV infusion bottles, thereby maintaining product integrity and compliance with regulatory standards.
Scope
This protocol applies to the Stoppering Machine used in the production area for IV Infusions (LVP/SVP – Bags/Bottles). It encompasses all aspects of equipment operation, critical parameters, and acceptance criteria as defined in the User Requirements Specification (URS) Annex11.
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 operating the Stoppering Machine during the PQ testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the Stoppering Machine operation.
- Availability of necessary materials and equipment for testing.
Equipment Description
The Stoppering Machine is designed to automatically place stoppers onto bottles in the production line for IV infusions. The equipment is critical in ensuring that the stoppers are accurately placed to prevent contamination and maintain product sterility.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify placement accuracy of stoppers. | Placement accuracy must be within ±0.5 mm. | Measurement records and photographic evidence. |
| PQ-02 | Audit reject logic functionality. | Reject logic must activate for improper placements. | System logs and audit trail records. |
| PQ-03 | Review audit trail for integrity. | Audit trail must be complete and tamper-proof. | Audit trail report. |
Detailed Test Cases
Test Case: PQ-01
Objective: To verify the accuracy of stopper placement.
Procedure: Measure the distance from the bottle rim to the stopper using calipers at multiple points.
Expected Result: All measurements should fall within the acceptance criteria of ±0.5 mm.
Test Case: PQ-02
Objective: To ensure reject logic functions correctly.
Procedure: Simulate improper stopper placement and verify that the system triggers a reject.
Expected Result: The system should reject the bottle and log the event in the audit trail.
Test Case: PQ-03
Objective: To confirm the integrity of the audit trail.
Procedure: Review the audit trail for completeness and check for any unauthorized changes.
Expected Result: The audit trail must show no gaps or unauthorized modifications.
Deviations
Any deviations from the acceptance criteria or procedures must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals
All results and deviations must be reviewed and approved by the Quality Assurance team prior to finalizing the PQ protocol.