Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Coding/Printing Machine in Ophthalmics Packaging
Objective: To validate the performance of the Coding/Printing Machine used for printing batch and expiry dates on sterile eye drops and ointments, ensuring compliance with regulatory requirements.
Scope: This protocol applies to the Coding/Printing Machine located in the Packaging/Primary area used for ophthalmic products.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the machine is in good working condition prior to testing.
Prerequisites:
- Machine installation and operational qualification completed.
- Personnel trained on the use of the Coding/Printing Machine.
- Availability of required materials and equipment for testing.
Equipment Description:
The Coding/Printing Machine is designed for printing batch and expiry information on primary packaging for sterile eye drops and ointments. It operates under controlled conditions to ensure print quality and integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Perform print quality verification audit trail. | Print quality meets specifications as per URS Annex11. | Print quality report and audit trail documentation. |
| PQ-02 | Verify data integrity checks on print outputs. | Data integrity checks confirm no discrepancies. | Data integrity check report. |
Detailed Test Cases:
- Test Case PQ-01: Verify the print quality by inspecting printed samples for legibility, clarity, and adherence to specified formats.
- Test Case PQ-02: Conduct data integrity checks by comparing printed batch/expiry dates against the electronic records to ensure consistency and accuracy.
Deviations:
Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the PQ protocol results.
Approvals:
Signature: ____________________ Date: ____________
Signature: ____________________ Date: ____________