Performance Qualification Protocol for Vision System in Packaging and Inspection
Document Control:
Document Number: PQ-VS-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Vision System used for label and code verification in the packaging process meets predefined acceptance criteria and operates as intended.
Scope
This protocol applies to the Vision System utilized in the Packaging/Inspection area for Solid Dosage Forms (OSD) and encompasses all relevant operational aspects, including detection accuracy, reject logic, and audit trail functionality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with the acceptance criteria. The Quality Assurance (QA) department will review and approve the final report.
Prerequisites
All personnel involved in this PQ must be trained on the operation of the Vision System and understand the validation process. Calibration of the Vision System must be completed prior to execution of this protocol.
Equipment Description
The Vision System is a critical component used for verifying the correctness of labels and codes on solid dosage forms. It is designed to detect misprints and ensure compliance with product specifications.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Verify detection accuracy of labels | Must detect 99.5% of misprints | Test results log |
| TP-02 | Audit trail functionality check | Audit trail must log all actions | Audit log report |
| TP-03 | Reject logic validation | System must reject 100% of incorrect labels | Rejection report |
Detailed Test Cases
Test Case 1: Detection Accuracy
Procedure: Run a set of known misprinted labels through the Vision System and record detection results.
Acceptance Criteria: The system must accurately detect 99.5% of misprints.
Test Case 2: Audit Trail Functionality
Procedure: Perform various operations on the Vision System and verify that all actions are logged in the audit trail.
Acceptance Criteria: All actions must be logged without exception.
Test Case 3: Reject Logic
Procedure: Feed incorrect labels into the Vision System and observe the rejection process.
Acceptance Criteria: The system must reject 100% of incorrect labels.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A report will be generated outlining the nature of the deviation and corrective actions taken.
Approvals
Prepared By: [Insert Name] Date: [Insert Date]
Approved By: [Insert Name] Date: [Insert Date]
CSV Requirements
Data Integrity Checks:
- Ensure all input data is validated before processing.
- Regularly back up audit trails to prevent data loss.
- Implement user access controls to restrict unauthorized changes.