Qualification and Validation of HVAC Systems in Pharmaceutical Facilities According to cGMP
Heating, Ventilation, and Air Conditioning (HVAC) systems are critical components in pharmaceutical manufacturing environments. These systems directly influence product quality, regulatory compliance, and environmental control, especially in cleanrooms and classified areas. Adhering to Current Good Manufacturing Practices (cGMP), as outlined by regulatory authorities such as the FDA, EMA, and WHO, is essential to ensure that HVAC systems are properly designed, validated, and maintained to prevent contamination and ensure product safety.