Document Control Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Coding Machine in Packaging
Objective: To validate the performance of the Coding Machine used for printing batch and expiry dates on sterile powders and lyophilized products, ensuring compliance with quality standards and regulatory requirements.
Scope: This protocol applies to the Performance Qualification of the Coding Machine utilized in the packaging area for sterile powders and lyophilized products. It encompasses all activities related to the validation of print quality and audit trail logs.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
- Operations: Provides access to the equipment and assists in the execution of the test plan.
Prerequisites:
- Installation Qualification (IQ) and Operational Qualification (OQ) completed and approved.
- Training of personnel on the Coding Machine operation.
- Availability of necessary materials for testing.
Equipment Description:
The Coding Machine is designed to print batch and expiry information on sterile powders and lyophilized products. It operates under controlled conditions to ensure the integrity of the printed information.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Perform print quality audit trail log check. | Audit trail logs must be complete and accurate as per URS Annex11. | Audit trail log report. |
| PQ-002 | Verify print clarity and legibility. | Print must be clear and legible without smudging. | Photographic evidence of prints. |
Detailed Test Cases:
- Test Case 1: Review the print quality audit trail logs for completeness. All entries must reflect the date and time of printing.
- Test Case 2: Inspect printed labels for clarity and legibility. Ensure no smudges or misprints are present.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan will be developed to address any identified issues.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________