FDA 483 HVAC cleaning failures – Pharma GMP

Cleaning of HVAC Filters: Often Ignored, Always Penalized

digi — Fri, 14 Nov 2025 10:41:14 +0000

Cleaning of HVAC Filters: Often Ignored, Always Penalized HVAC Filter Cleaning in GMP Facilities: A Neglected Risk with Serious Compliance Consequences Introduction: Why This Topic Matters for GMP Compliance Heating, Ventilation, and Air Conditioning (HVAC) systems play a critical role in maintaining cleanroom environments, controlling particulate and microbial contamination, and ensuring product quality in pharmaceutical...

HVAC Cleaning SOP: What Inspectors Want to See

digi — Fri, 14 Nov 2025 10:39:43 +0000

HVAC Cleaning SOP: What Inspectors Want to See HVAC Cleaning SOPs: Key Regulatory Expectations for GMP Audits Introduction: Why This Topic Matters for GMP Compliance Heating, Ventilation, and Air Conditioning (HVAC) systems are vital for maintaining cleanroom integrity and preventing contamination in GMP-regulated facilities. Regulators consistently emphasize the importance of having robust HVAC cleaning SOPs...