Document Control
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Vision System in Nasal and Otic Products
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Vision System used for the packaging and inspection of nasal and otic products meets the specified requirements and functions as intended.
Scope
This protocol applies to the Vision System used in the Packaging/Inspection area for both sterile and non-sterile nasal and otic products.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Operations: Ensure equipment is maintained and calibrated prior to testing.
Prerequisites
- Equipment must be installed and operational.
- Personnel must be trained on the operation of the Vision System.
- All necessary documentation must be available, including URS and CSV requirements.
Equipment Description
The Vision System is designed for the inspection of printed data on packaging for nasal and otic products. It utilizes advanced imaging technology to ensure the accuracy of printed information.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify read rate | Read rate must be ≥ 98% | Read rate report |
| TP-002 | Reject logic audit trail | Audit trail must show no unauthorized changes | Audit trail report |
Detailed Test Cases
Test Case 1: Verify Read Rate
Procedure: Execute the read rate test using a sample batch of packaging.
Acceptance Criteria: The read rate must be ≥ 98%.
Evidence: Documented read rate results.
Test Case 2: Reject Logic Audit Trail
Procedure: Review the audit trail for any unauthorized changes during the inspection process.
Acceptance Criteria: The audit trail must show no unauthorized changes.
Evidence: Documented audit trail review.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions must be implemented as necessary.
Approvals
____________________
Validation Team Lead
____________________
Quality Assurance Manager