Standard Operating Procedure for Visual Inspection

Purpose

The purpose of this SOP is to establish procedures for the systematic and thorough visual inspection of pharmaceutical products, ensuring compliance with regulatory standards and maintaining product quality.

Scope

This SOP applies to all personnel involved in the visual inspection process, including operators, inspectors, and quality control personnel.

Responsibilities

• Operators: Responsible for conducting visual inspections during the manufacturing process.
• Inspectors: Responsible for detailed and formal visual inspections of finished products.
• Quality Control Personnel: Responsible for monitoring and verifying visual inspections for compliance.

Procedure

1. Ensure that the visual inspection area is well-lit and free from distractions that could impact the inspection process.
2. Verify that personnel conducting visual inspections are adequately trained and qualified for the task.
3. For in-process visual inspections, ensure that operators follow defined procedures for detecting and addressing defects.
4. For finished product inspections, use appropriate magnification tools and lighting to aid in the inspection process.
5. Inspect each unit for characteristics such as color, shape, size, labeling, and other visual attributes specified in the product specifications.
6. Verify that packaging materials (e.g., blister packs, labels) are correctly applied and in good condition.
7. Record the results of visual inspections, including any defects or deviations found, in the designated logbook or electronic system.
8. If defects are identified during visual inspection, segregate and document affected units, and initiate an investigation to determine the root cause.
9. Implement corrective actions based on the findings of the investigation to prevent the recurrence of defects.
10. For finished product batches, ensure that the required sampling plan for visual inspection is followed, and document the results accordingly.
11. Document any out-of-specification (OOS) results, initiate an investigation, and implement corrective actions as needed.
12. Archive visual inspection records in accordance with established retention policies.
13. Regularly review and update visual inspection procedures based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Visual Inspection Logbook
• Defect Classification Guide
• Deviation and Corrective Action Logs

Reference

USP General Chapter <790> – Visual Inspection of Injections

SOP Version

Version 1.0