HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control The HVAC (Heating, Ventilation, and Air Conditioning) system in pharmaceutical manufacturing environments is critical to maintaining cleanroom standards, ensuring product sterility, and complying with GMP regulations. Proper qualification of HVAC systems ensures that airflow, filtration, pressure differentials, temperature, and humidity parameters meet the defined specifications throughout the facility’s lifecycle. This article provides a comprehensive, step-by-step approach to HVAC system qualification, aligned with FDA, EMA Annex 1, and WHO GMP expectations. Why HVAC Qualification Matters in Pharma HVAC systems directly impact…