Do Not Allow Flaking Paint in GMP Controlled Manufacturing Environments

Flaking Paint Must Be Eliminated from GMP Controlled Areas

Remember: Peeling paint is an unacceptable contamination source in GMP areas—facilities must be maintained to prevent such physical degradation.

Why This Matters in GMP

Facility walls and ceilings must be constructed and maintained to minimize particle generation and ensure easy cleaning. Flaking or peeling paint is a significant contamination risk, especially in areas where raw materials, intermediates, or finished products are exposed. Detached paint particles can enter product containers or processing equipment, leading to batch contamination, product recalls, or health hazards. GMP requires facility surfaces to be intact, cleanable, and resistant to sanitizing agents. Unmaintained surfaces reflect poor facility upkeep and undermine the confidence of regulators, auditors, and clients.

Also Read: Periodically Verify Water for Injection (WFI) Quality in GMP Operations

Regulatory and Compliance Implications

FDA 21 CFR Part 211.42 requires facilities to be maintained in a clean and sanitary condition. EU GMP Chapter 3 and WHO GMP specify that internal surfaces in clean areas must be free from cracks, flaking paint, and other damage. Schedule M mandates periodic facility inspection and immediate repair of deteriorating structures. Regulatory bodies treat flaking paint as a direct contamination hazard, often issuing 483s or non-conformance reports upon observation. Regular facility inspections and timely maintenance are essential for GMP facility compliance.

Implementation Best Practices

Inspect facility walls, ceilings, and door frames weekly for signs of peeling, cracks, or discoloration.
Use epoxy or antimicrobial-grade paints specifically formulated for GMP environments.
Document all maintenance actions including patching, sanding, and repainting in QA-reviewed logs.
Quarantine areas undergoing repair to prevent exposure to ongoing manufacturing.
Train housekeeping and engineering staff to report and document any surface degradation.

Also Read: How Lean Manufacturing Improves Product Consistency and GMP Compliance

Regulatory References

FDA 21 CFR Part 211.42 – Design and Construction Features
EU GMP Chapter 3 – Premises and Equipment
WHO GMP – Cleanroom Surface Requirements
Schedule M – Facility Maintenance and Surface Coating