Standard Operating Procedure for Equipment Validation of Vision System

Purpose

This SOP outlines the process for validating the Vision System used for label and code verification in the packaging of solid dosage forms to ensure compliance with regulatory standards and product integrity.

Scope

This procedure applies to the Vision System utilized in the Packaging/Inspection area for verifying print and label correctness. It includes all phases of validation: DQ, IQ, OQ, and PQ.

Definitions

• Vision System: A system used to verify the correctness of printed labels and codes on solid dosage forms.
• Validation: The process of establishing documented evidence that a system operates consistently within predetermined limits.
• Criticality: The significance of the equipment in ensuring product quality and compliance.

Roles

• Validation Engineer: Responsible for planning, executing, and documenting validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Operations Personnel: Operates the Vision System and provides feedback during validation activities.

Lifecycle Procedure

1. Design Qualification (DQ): Document requirements and specifications for the Vision System.
2. Installation Qualification (IQ): Verify that the equipment is installed according to specifications.
3. Operational Qualification (OQ): Test the system’s functionality and performance under normal operating conditions.
4. Performance Qualification (PQ): Validate the system’s ability to produce acceptable results over a defined period.

GDP Controls

Good Documentation Practices (GDP) must be adhered to throughout the validation process, ensuring all records are clear, concise, and traceable.

Acceptance Criteria Governance

Acceptance criteria for the Vision System validation will follow the User Requirement Specification (URS) and Annex 11 guidelines to ensure compliance with regulatory standards.

Calibration/PM Governance

The Vision System must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal SOPs to ensure consistent performance.

Change Control Triggers

Any changes to the Vision System, including software updates, hardware modifications, or changes in operational procedures, will trigger a change control process and may necessitate revalidation.

Revalidation Triggers and Periodic Review

Revalidation of the Vision System is required every 12 months or whenever there are significant changes to the system or its operating environment.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration Records
• Change Control Documentation
• Periodic Review Records