Performance Qualification Protocol for Automated Visual Inspection Machine
Document Control:
- Document Number: PQ-AVIM-001
- Version: 1.0
- Effective Date: 2023-10-01
- Reviewed by: Quality Assurance
- Approval Date: 2023-10-01
Objective:
The objective of this Performance Qualification (PQ) protocol is to ensure that the Automated Visual Inspection Machine consistently performs its intended function of inspecting prefilled syringes and cartridges, meeting defined acceptance criteria.
Scope:
This protocol applies to the Automated Visual Inspection Machine used in the production area for inspecting prefilled syringes and cartridges. It covers all aspects of performance qualification, including critical parameters and acceptance criteria.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for operating the equipment during the qualification process.
Prerequisites:
- Equipment installation and operational qualification must be completed.
- Personnel must be trained on the operation of the Automated Visual Inspection Machine.
- Standard Operating Procedures (SOPs) for the operation and maintenance of the equipment must be available.
Equipment Description:
The Automated Visual Inspection Machine is designed to inspect prefilled syringes and cartridges for defects such as particulates, container integrity, and other visual anomalies. The machine utilizes advanced imaging technology and algorithms to perform inspections with high accuracy.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001 | Conduct inspection accuracy tests with a defined sample size. | Inspection accuracy ≥ 99% | Inspection report and data logs |
| PQ-002 | Verify reject logic functionality with known defect samples. | Reject logic functions correctly for 100% of defects. | Test results and logs |
| PQ-003 | Audit trail log review for completeness and accuracy. | All actions logged with timestamps and user IDs. | Audit trail report |
Detailed Test Cases:
- Test Case PQ-001: Use a sample of 100 syringes, 1% known defects. Measure the inspection accuracy and document results.
- Test Case PQ-002: Introduce 10 known defects and confirm that the machine rejects all defective items.
- Test Case PQ-003: Review the audit trail for the last 30 days to ensure all inspections are documented with appropriate timestamps.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
- Prepared by: [Name], Validation Team
- Reviewed by: [Name], Quality Assurance
- Approved by: [Name], Management
Data Integrity Checks:
- Regular backup of inspection data.
- Access controls to prevent unauthorized changes to inspection parameters.
- Validation of data transfer processes to ensure no data loss.