Equipment Validation SOP for Automated Visual Inspection Machine
Purpose: This SOP outlines the procedures for validating the Automated Visual Inspection Machine used for inspecting prefilled syringes and cartridges to ensure compliance with regulatory standards and product quality.
Scope: This procedure applies to the validation of the Automated Visual Inspection Machine in the Production area, specifically for the inspection of prefilled syringes and cartridges.
Definitions:
- Automated Visual Inspection Machine: A device used to inspect the integrity and quality of prefilled syringes and cartridges.
- Validation: The process of establishing documented evidence that a system meets its intended use.
- Criticality: The level of impact a failure may have on product quality and patient safety.
Roles:
- Validation Team: Responsible for planning and executing validation activities.
- Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
- Production Personnel: Operate the equipment and provide feedback on its performance.
Lifecycle Procedure:
- Design Qualification (DQ): Verify that the design of the equipment meets user requirements.
- Installation Qualification (IQ): Confirm that the equipment is installed correctly and according to specifications.
- Operational Qualification (OQ): Ensure the equipment operates according to its intended use under normal operating conditions.
- Performance Qualification (PQ): Validate that the equipment performs effectively in a production environment.
GDP Controls: Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are complete, accurate, and traceable.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirement Specifications (URS) and will comply with Annex 11 of the applicable regulatory guidelines.
Calibration/PM Governance: The Automated Visual Inspection Machine must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies.
Change Control Triggers: Any changes to the equipment, process, or related documentation must be assessed for impact on the validation status and handled through the change control process.
Revalidation Triggers and Periodic Review: Revalidation will occur annually, or upon significant changes to the equipment, process, or product that may impact its performance.
Records/Attachments List:
- Validation Plan
- Validation Protocols (DQ, IQ, OQ, PQ)
- Validation Reports
- Calibration Records
- Preventive Maintenance Records
- Change Control Documentation