PHARMA KING ACE

HVAC Validation in Pharmaceutical Industry – A Complete Guide Introduction In pharmaceutical manufacturing, maintaining a controlled environment is crucial for product quality and patient safety. Heating, Ventilation, and Air Conditioning (HVAC) systems play a vital role in ensuring controlled temperature, humidity, air quality, and cleanliness. To comply with regulatory requirements (US FDA, EU GMP, WHO), HVAC systems must undergo a rigorous validation process that demonstrates their reliability and effectiveness. What is HVAC Validation? HVAC Validation is the documented process of proving that the installed HVAC system performs consistently as designed, maintains cleanroom classifications, and prevents contamination in manufacturing areas (especially in OSD, Sterile, and Biotech facilities). It covers: Design Qualification (DQ) – Ensuring system design meets GMP requirements. Installation Qualification (IQ) – Verifying correct installation of AHUs, ducts, HEPA filters, sensors, etc....