Equipment Validation SOP for Automated Visual Inspection Machine in Ophthalmics
Purpose: This SOP outlines the validation process for the Automated Visual Inspection (AVI) Machine used in the production of sterile eye drops and eye ointments, ensuring compliance with regulatory standards and product quality.
Scope: This SOP applies to the validation of the AVI Machine utilized in the production area for inspecting particulates and cosmetics in ophthalmic products.
Definitions:
- AVI Machine: Automated Visual Inspection Machine used for inspecting ophthalmic products.
- Criticality: Indicates the importance of the equipment to product quality; in this case, it is critical.
- DQ/IQ/OQ/PQ: Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification.
Roles:
- Validation Team: Responsible for executing and documenting the validation process.
- Quality Assurance: Oversees compliance with regulatory requirements and reviews validation documentation.
- Production Personnel: Operate the AVI Machine and maintain records of its use.
Lifecycle Procedure:
- Design Qualification (DQ): Confirm that the AVI Machine meets user requirements and specifications.
- Installation Qualification (IQ): Verify that the machine is installed correctly and is operational.
- Operational Qualification (OQ): Assess the machine’s performance under normal operating conditions.
- Performance Qualification (PQ): Validate the machine’s ability to consistently perform as intended in a production environment.
GDP Controls: Good Documentation Practices must be adhered to throughout the validation process, ensuring all records are accurate, complete, and retrievable.
Acceptance Criteria Governance: Acceptance criteria will be established in accordance with the User Requirement Specification (URS) and Annex 11 guidelines to ensure that the AVI Machine meets all operational and regulatory requirements.
Calibration/PM Governance: The AVI Machine must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies to ensure ongoing accuracy and reliability.
Change Control Triggers: Any changes to the equipment, process, or personnel that may affect the validation status must be documented and assessed through the change control process.
Revalidation Triggers and Periodic Review: Revalidation will occur annually or if significant changes are made to the equipment or process. A periodic review of the validation status will be conducted every 12 months.
Records/Attachments List:
- Validation Protocols
- Calibration Records
- Maintenance Logs
- Change Control Documentation
- Periodic Review Reports