Air Quality Matters: A Holistic Strategy and Approach to HVAC System Validation in Pharmaceuticals

Abstract

Heating, ventilation, and air conditioning (HVAC) systems plays a critical role in pharmaceutical manufacturing facilities by ensuring the integrity of product quality, safety, and compliance with regulatory requirements. HVAC validation is an essential process that verifies and documents the performance and effectiveness of these systems. This review paper explores various strategies and approaches to HVAC validation in pharmaceutical manufacturing facilities, including regulatory considerations, validation methodologies, risk assessment, and ongoing monitoring. The paper also discusses the challenges associated with HVAC validation and presents best practices to improve the effectiveness of the validation process.