Standard Operating Procedure for Visual Inspection of Vials

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the visual inspection of vials to ensure they are free from defects and contamination.

2) Scope

This SOP applies to all vials used for the packaging of pharmaceutical products within the facility.

3) Responsibilities

3.1 Inspection Personnel
– Conduct visual inspections as per this SOP.
– Document and report inspection results accurately.
3.2 Production Supervisor
– Ensure all inspection procedures are followed.
– Review and approve inspection records.
3.3 Quality Assurance (QA) Personnel
– Validate visual inspection methods.
– Ensure compliance with regulatory guidelines.

4) Procedure

4.1 Preparation
4.1.1 Clean and disinfect the inspection area and equipment.
4.1.2 Ensure proper lighting and magnification tools are available for inspection.
4.2 Sampling
4.2.1 Collect samples aseptically to prevent contamination.
4.2.2 Transport samples to the inspection area in appropriate containers.
4.3 Inspection Methods
4.3.1 Inspect vials for visible particles, cracks, and other defects.
4.3.2 Use both manual and automated inspection systems for thorough examination.
4.4 Monitoring and Documentation
4.4.1 Monitor the inspection process to ensure consistency and accuracy.
4.4.2 Record observations and inspection results in the Visual Inspection Log.
4.5 Reporting
4.5.1 Compile inspection results and prepare a visual inspection report.
4.5.2 Submit the report to QA for review and approval.
4.6 Investigation of Defects
4.6.1 Investigate any defects found during inspection to determine the cause.
4.6.2 Implement corrective actions to prevent recurrence.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Visual Inspection Log
– Visual Inspection Reports
– Inspection Equipment Calibration Records

7) Reference, if any

– United States Pharmacopeia (USP) <1790> Visual Inspection of Injectable Products
– European Pharmacopoeia (Ph. Eur.) 2.9.20 Particulate Contamination: Visible Particles

8) SOP Version

Version 1.0