Perform Visual Inspection of Vials Using Qualified Lighting Conditions

Visually Inspect Vials Under Qualified Lighting Before Release

Remember: Every vial must be inspected under standardized lighting to detect defects and comply with GMP sterile product requirements.

Why This Matters in GMP

Visual inspection is a critical quality control step in sterile manufacturing, especially for injectable products. Vials must be examined under defined lighting conditions to detect particles, cracks, discoloration, improper seals, or fill volume inconsistencies. Poor lighting or untrained inspection techniques may result in overlooked defects, posing serious health risks to patients. Inspection must be standardized, validated, and performed by qualified personnel in designated booths. Inconsistent practices can result in defective product release, batch recalls, and regulatory penalties. GMP demands this inspection step as part of the final release criteria for parenteral products.

Also Read: How to Incorporate FDA GMP Guidelines into Your Pharmaceutical Quality Management System (QMS)

Regulatory and Compliance Implications

FDA 21 CFR Part 211.160 and 211.165 require visual examination of sterile drug products for visible particulates. EU GMP Annex 1 mandates 100% visual inspection using validated systems or qualified operators. WHO GMP and Schedule M prescribe lighting requirements and inspection procedures to ensure defect detection. Regulatory agencies scrutinize inspection logs, lighting validation records, and defect classification protocols. Failure to comply with inspection requirements can result in Form 483s, warning letters, or product recalls. A well-documented, validated visual inspection process is key to sterile product integrity.

Implementation Best Practices

Use inspection booths with calibrated lighting between 2000–3750 lux, as per guidelines.
Train and qualify inspectors periodically with blind defect sets.
Develop SOPs defining inspection criteria, lighting settings, and defect classification.
Record inspection outcomes per batch and segregate defective units with traceable logs.
Review trends in defect detection to improve process controls upstream.

Also Read: Verify Batch Yield Calculations Before Finalizing Manufacturing Records

Regulatory References

FDA 21 CFR Part 211.160 – General Requirements for Laboratory Controls
FDA 21 CFR Part 211.165 – Testing and Release for Distribution
EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
WHO GMP – Visual Inspection of Parenterals
Schedule M – Inspection and Testing of Finished Products