Standard Operating Procedure for Automated Visual Inspection System Validation
Purpose: This SOP outlines the validation process for the Automated Visual Inspection (AVI) System used in NDDS Packaging and Integrity, ensuring compliance with regulatory requirements and maintaining product quality.
Scope: This procedure applies to the Automated Visual Inspection System utilized in the Production area for the inspection of particulate and cosmetic defects in products.
Definitions:
- AVI: Automated Visual Inspection.
- NDDS: Novel Drug Delivery Systems.
- DQ: Design Qualification.
- IQ: Installation Qualification.
- OQ: Operational Qualification.
- PQ: Performance Qualification.
Roles:
- Validation Team: Responsible for the execution of validation activities.
- Quality Assurance: Ensures compliance with validation protocols and regulatory standards.
- Production Personnel: Operate the AVI System and ensure adherence to SOPs.
Lifecycle Procedure:
- Design Qualification (DQ): Document requirements and specifications for the AVI System.
- Installation Qualification (IQ): Verify that the system is installed correctly and meets design specifications.
- Operational Qualification (OQ): Test the system under operational conditions to ensure it functions as intended.
- Performance Qualification (PQ): Validate the system’s performance in real-world scenarios.
GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are clear, complete, and accurate.
Acceptance Criteria Governance: Acceptance criteria will be governed by the User Requirements Specification (URS) and Annex 11 compliance.
Calibration/PM Governance: The AVI System must undergo regular calibration and preventive maintenance as per the manufacturer’s guidelines and internal policies.
Change Control Triggers: Any changes to the AVI System or its operating environment must be evaluated through the Change Control process to assess impact on validation status.
Revalidation Triggers and Periodic Review: The AVI System requires revalidation every 12 months or when significant changes occur that may affect its performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Records
- Training Records