Performance Qualification Protocol for Coding Machines Used in Packaging of Prefilled Syringes and Cartridges
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Coding Machine (Laser / Inkjet) used for printing batch and expiry information on prefilled syringes and cartridges, ensuring compliance with regulatory requirements and product integrity.
Scope
This protocol applies to the Coding Machine utilized in the packaging area for prefilled syringes and cartridges, impacting product quality directly.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Review and approval of the protocol and final report.
- Operations: Ensure the equipment is maintained and calibrated as per the requirements.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Coding Machine.
- Availability of necessary materials and equipment for testing.
Equipment Description
The Coding Machine (Laser / Inkjet) is designed to print batch and expiry dates on prefilled syringes and cartridges. It incorporates advanced technology to ensure high-quality print output, critical for maintaining product traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify print quality and clarity of batch and expiry information. | Print must be legible and meet specifications outlined in URS Annex11. | Print samples and photographic evidence. |
| PQ-002 | Audit trail log verification. | Audit trail must be complete and accurate, with no gaps. | Audit trail log report. |
Detailed Test Cases
Test Case 1: Print Quality Verification
Objective: To ensure that the print quality meets the specified standards.
Procedure: Run the Coding Machine and print a series of samples. Evaluate each sample for clarity, alignment, and legibility.
Acceptance Criteria: All samples must be clear and legible as per URS Annex11.
Evidence: Documented results with photographic evidence.
Test Case 2: Audit Trail Verification
Objective: To confirm the integrity of the audit trail logs.
Procedure: Review the audit trail logs for completeness, ensuring all entries are accurate and time-stamped.
Acceptance Criteria: No gaps or inaccuracies in the audit trail.
Evidence: Printed audit trail log report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.
Approvals
This protocol must be approved by the Quality Assurance department prior to execution.