Document Control:
Document ID: PQ-VIS-001
Version: 1.0
Effective Date: YYYY-MM-DD
Review Date: YYYY-MM-DD
Performance Qualification Protocol for Vision Inspection System
Objective: To validate the performance of the Vision Inspection System for inspecting defects and ensuring packaging integrity of suppositories and implants.
Scope: This protocol applies to the Vision Inspection System used in the packaging area for direct impact products, specifically suppositories and implants.
Responsibilities:
- Validation Team: Conduct the PQ tests and document results.
- Quality Assurance: Review and approve the PQ protocol and results.
- Operations: Ensure equipment is maintained and calibrated prior to testing.
Prerequisites:
- Equipment must be installed and calibrated according to the manufacturer’s specifications.
- Personnel must be trained on the operation of the Vision Inspection System.
- Relevant standard operating procedures (SOPs) must be in place.
Equipment Description:
The Vision Inspection System is designed to inspect packaging integrity and detect defects in suppositories and implants. It utilizes advanced imaging technology to identify and reject non-conforming products based on predefined criteria.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-VIS-01 | Verify detection accuracy | Detection accuracy ≥ 98% | Test results log |
| PQ-VIS-02 | Test reject logic | Reject logic functions correctly | System log files |
| PQ-VIS-03 | Audit trail verification | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases:
- Test Case 1: Conduct a detection accuracy test using a sample of known defective and non-defective products. Record the results and calculate the detection accuracy percentage.
- Test Case 2: Execute the reject logic by introducing defective products and verifying that they are correctly rejected by the system.
- Test Case 3: Review the audit trail generated during the testing phase to ensure all actions are recorded and retrievable.
Deviations: Any deviations from the protocol must be documented, including the nature of the deviation, reason, and corrective actions taken.
Approvals:
- Prepared by: ____________________ Date: ___________
- Reviewed by: ____________________ Date: ___________
- Approved by: ____________________ Date: ___________
Data Integrity Checks:
- Ensure all test results are automatically logged by the system.
- Verify that the audit trail captures all user interactions with the Vision Inspection System during the PQ process.
- Conduct periodic checks to confirm that data is backed up and retrievable.